00-884. Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I  

  • [Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
    [Rules and Regulations]
    [Pages 2296-2323]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 00-884]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 
    884, 886, 888, 890, and 892
    
    [Docket No. 98N-0009]
    
    
    Medical Devices; Exemption From Premarket Notification and 
    Reserved Devices; Class I
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule.
    
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    SUMMARY: The Food and Drug Administration (FDA) is amending its 
    classification regulations to designate class I devices that are exempt 
    from the premarket notification requirements, subject to certain 
    limitations, and to designate those class I devices that remain subject 
    to premarket notification requirements under the new statutory criteria 
    for premarket notification requirements. The devices FDA is designating 
    as exempt do not include class I devices that have been previously 
    exempted by regulation from the premarket notification requirements. 
    This action is being taken under the Federal Food, Drug, and Cosmetic 
    Act (the act), as amended by the Medical Device Amendments of 1976 (the 
    1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the 
    FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in 
    order to implement a requirement of FDAMA. Elsewhere in this issue of 
    the Federal Register, FDA is announcing that it is withdrawing proposed 
    rules to revoke existing exemptions from premarket notification for two 
    devices.
    
    DATES: This regulation is effective February 14, 2000.
    
    FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
    Devices and Radiological Health (HFZ-404), Food and Drug 
    Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
    1190.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Statutory Background
    
        Under section 513 of the act (21 U.S.C. 360c), FDA must classify 
    devices into one of three regulatory classes: Class I, class II, or 
    class III. FDA classification of a device is determined by the amount 
    of regulation necessary to provide a reasonable assurance of safety and 
    effectiveness. Under the 1976 amendments (Public Law 94-295), as 
    amended by the SMDA (Public Law 101-629), devices are to be classified 
    into class I (general controls) if there is information showing that 
    the general controls of the act are sufficient to ensure safety and 
    effectiveness; into class II (special controls), if general controls, 
    by themselves, are insufficient to provide reasonable assurance of 
    safety and effectiveness, but there is sufficient information to 
    establish special controls to provide such assurance; and into class 
    III (premarket approval), if there is insufficient information to 
    support classifying a device into class I or class II and the device is 
    a life-sustaining or life-supporting device, or is for a use which is 
    of substantial importance in preventing impairment of human health, or 
    presents a potential unreasonable risk of illness or injury.
        Most generic types of devices that were on the market before the 
    date of the 1976 amendments (May 28, 1976) (generally referred to as 
    preamendments devices) have been classified by FDA under the procedures 
    set forth in section 513(c) and (d) of the act through the issuance of 
    classification regulations into one of these three regulatory classes. 
    Devices introduced into interstate commerce for the first time on or 
    after May 28, 1976 (generally referred to as postamendments devices) 
    are classified through the premarket notification process under section 
    510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
    implementing regulations, part 807 (21 CFR part 807), require persons 
    who intend to market a new device to submit a premarket notification 
    report (510(k)) containing information that allows FDA to determine 
    whether the new device is substantially equivalent within the meaning 
    of section 513(i) of the act to a legally marketed device that does not 
    require premarket approval. Unless exempted from premarket notification 
    requirements, persons may not market a new device under section 510(k) 
    of the act, unless they receive a substantial equivalence order from 
    FDA or an order reclassifying the device into class I or class II, 
    under section 513(f) of the act.
        On November 21, 1997, the President signed FDAMA into law (Public 
    Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l) 
    to the act. Under section 206 of FDAMA, new section 510(l) of the act 
    became effective on February 19, 1998. New section 510(l) of the act 
    provides that a class I device is exempt from the premarket 
    notification requirements under section 510(k) of the act, unless the 
    device is intended for a use which is of substantial importance in 
    preventing impairment of human health or it presents a potential 
    unreasonable risk of illness or injury. This document refers to devices 
    that FDA believes meet these criteria as ``reserved.'' FDA has 
    evaluated all class I devices to determine which device types should be 
    subject to premarket notification requirements.
        In developing the list of reserved devices, the agency considered 
    its experience in reviewing premarket notifications for these device 
    types, focusing on the risk inherent with the device and/or the disease 
    being treated or diagnosed. FDA believes that the devices listed as 
    reserved are intended for a use that is of substantial importance in 
    preventing impairment of human health or present a potential 
    unreasonable risk of illness or injury.
    
    II. Limitations on Exemptions
    
        FDA believes that the generic types of class I devices listed 
    herein, in addition to a vast majority of class I devices previously 
    exempted, should be exempt from the premarket notification requirements 
    under section 510(l) of the act. FDA further believes, however, that 
    these generic device categories should be exempt only to the extent 
    that they have existing or reasonably foreseeable characteristics of 
    commercially distributed devices within that generic type or, in the 
    case of in vitro diagnostic devices (IVD's), only to the extent that 
    misdiagnosis as a result of using the device would not be associated 
    with high morbidity or mortality. FDA believes that certain changes to 
    devices within a generic device type that is generally exempt may make 
    the device intended for a use that is of substantial importance in 
    preventing impairment of human health or may make the device present a 
    potential unreasonable risk of illness or injury. Accordingly, devices 
    changed in this manner would fall within the reserved criteria under 
    section 510(l) of the act and would require premarket notification.
        FDA believes that devices that have different intended uses than 
    legally marketed devices in that generic device type present a 
    potential unreasonable risk of illness or injury because their safety 
    and effectiveness characteristics
    
    [[Page 2297]]
    
    are unknown. Moreover, FDA believes that IVD's are intended for a use 
    that is of substantial importance in preventing impairment of human 
    health or present a potential unreasonable risk of illness or injury, 
    if misdiagnosis, as a result of using the device, could result in high 
    morbidity or mortality.
        Accordingly, because FDA believes that devices incorporating the 
    characteristics described above fit within the reserved criteria under 
    section 510(l) of the act, FDA considers any class I device to be 
    subject to premarket notification requirements if the device: (1) Has 
    an intended use that is different from the intended use of a legally 
    marketed device in that generic type of device (e.g., the device is 
    intended for a different medical purpose, or the device is intended for 
    lay use instead of use by health care professionals); or (2) operates 
    using a different fundamental scientific technology than that used by a 
    legally marketed device in that generic type of device (e.g., a 
    surgical instrument cuts tissue with a laser beam rather than with a 
    sharpened metal blade, or an IVD detects or identifies infectious 
    agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid 
    hybridization or amplification technology rather than culture or 
    immunoassay technology); or (3) is an in vitro device that is intended: 
    (a) For use in the diagnosis, monitoring, or screening of neoplastic 
    diseases with the exception of immunohistochemical devices; (b) for use 
    in screening or diagnosis of familial and acquired genetic disorders, 
    including inborn errors of metabolism; (c) for measuring an analyte 
    that serves as a surrogate marker for screening, diagnosis, or 
    monitoring life threatening diseases such as acquired immune deficiency 
    syndrome (AIDS), chronic or active hepatitis, tuberculosis, or 
    myocardial infarction or to monitor therapy; (d) to assess the risk of 
    cardiovascular diseases; (e) for use in diabetes management; (f) to 
    identify or infer the identity of a microorganism directly from 
    clinical material; (g) for detection of antibodies to microorganisms 
    other than immunoglobulin G (IgG) and IgG assays when the results are 
    not qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma; (h) for 
    noninvasive testing as defined in Sec. 812.3(k) (21 CFR 812.3(k)); and 
    (9) for near patient testing (point of care). FDA is revising 
    Secs. 862.9, 864.9, and 866.9 (21 CFR 862.9, 864.9, and 866.9) to 
    incorporate these revised limitations on exemptions for IVD's. FDA 
    believes that these limitations, for the reasons described previously, 
    are appropriate for IVD's.
        FDA is also amending all current limitations on exemptions sections 
    (21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 874.9, 876.9, 878.9, 
    880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9) in two ways. 
    First, the limitations language clarifies that these limitations apply 
    to class II, as well as class I devices. On January 21, 1998 (63 FR 
    3142), FDA published a list of exempted class II devices, subject to 
    certain limitations. Under section 510(m)(1) of the act, as added by 
    FDAMA, FDA was provided the authority to exempt these class II devices 
    from premarket notification upon issuance of a notice. FDA codified 
    these exemptions, including the limitations described in the January 
    21, 1998, Federal Register notice, by issuance of a final rule on 
    November 3, 1998 (63 FR 59222).
        The limitations language in this document for class I devices is 
    identical to those limitations for class II devices that became 
    effective on January 21, 1998. Accordingly, the limitations sections 
    state that the scope of these limitations apply to class II, as well as 
    class I devices.
        Second, FDA is amending the limitations language to state that 
    premarket notifications must be submitted for class I exempt devices if 
    the intended use is different than the ``legally marketed devices in 
    that generic type.'' Currently, the limitations in each classification 
    regulation (e.g., Secs. 862.9, 864.9, etc.) state that manufacturers 
    must submit premarket notifications for class I exempt devices when 
    ``[t]he device is intended for a use different from its intended use 
    before May 28, 1976, or the device is intended for a use different from 
    the intended use of a preamendments device to which it had been 
    determined to be substantially equivalent;''. Devices that have an 
    intended use that differs from any legally marketed device are not 
    exempt because those devices present a potential unreasonable risk of 
    illness or injury because their safety and effectiveness 
    characteristics are unknown. Manufacturers of such devices must submit 
    a premarket notification and the agency will determine if they are 
    substantially equivalent to other legally marketed devices in that 
    generic device type.
        In addition to the general limitations on exemptions applicable to 
    all class I devices that are described previously, certain devices 
    within a generic class also remain subject to the premarket 
    notification requirements because they either are intended for a use 
    that is of substantial importance in preventing impairment of human 
    health or they present a potential unreasonable risk of illness or 
    injury. For example, elsewhere in this document, FDA states that liquid 
    bandages are generally exempt from the premarket notification 
    requirements, but a subcategory of those devices, those intended for 
    treatment of burns and other open wounds, remains subject to the 
    premarket notification requirements. FDA believes that liquid bandages 
    intended for burns and other open wounds should remain subject to this 
    requirement because they are of substantial importance in preventing 
    impairment of human health by helping to prevent infections.
        FDA also advises that an exemption from the requirement of 
    premarket notification does not mean that the device is exempt from any 
    other statutory or regulatory requirements, unless such exemption is 
    explicitly provided by order or regulation.
        The limitations in each classification regulation apply to the 
    premarket notification exemptions for each generic device classified in 
    each section. In addition to mentioning the limitations generally in 
    each classification regulation, FDA specifically states in the 
    classification sections for each generic device that is newly exempted 
    under section 510(l) of the act that the exemptions are subject to 
    limitations. For example, with this regulation Sec. 862.1200 states 
    that the corticosterone test system ``is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 862.9.'' (Emphasis added.) FDA is adding this language 
    specifically referring to the limitations language for clarity and 
    convenience.
        Individual device classification sections that have been codified 
    previously that are exempt from premarket notification requirements, 
    subject to limitations, do not specifically refer to the general 
    limitations section. For these classifications, FDA intends to codify 
    language in the near future that will mention the limitations sections 
    in each device classification.
    
    III. Analysis of Comments
    
        In the Federal Register of February 2, 1998 (63 FR 5387), FDA 
    published a list of devices it considered reserved and that require 
    premarket notification and a list of devices it believed met the 
    exemption criteria in FDAMA. FDA invited comments on the February 2, 
    1998, notice.
        In the Federal Register of November 12, 1998 (63 FR 63222), after 
    reviewing the comments submitted on the February 2, 1998, Federal 
    Register
    
    [[Page 2298]]
    
    notice, FDA proposed to designate which devices require premarket 
    notification, and which are exempt, subject to limitations, under 
    notice and comment rulemaking proceedings under new section 510(l) of 
    the act. FDA received four comments in response to the proposed rule. 
    The following is FDA's response to those comments.
        1. One comment in regard to unscented menstrual pads 
    (Sec. 884.5435) (21 CFR 884.5435)) stated that: (1) Interlabial pads do 
    not contact vaginal tissue; (2) interlabial pads should not be grouped 
    with reusable menstrual pads in the regulation because they have 
    different risks; and (3) the term ``intralabial'' is not accurate and 
    the correct nomenclature is ``interlabial.''
        Both interlabial pads and reusable pads are types of unscented 
    menstrual pads that meet the reserved criteria, and, therefore, must 
    meet the premarket notification requirements. Other types of unscented 
    menstrual pads are exempt. Although FDA agrees that interlabial pads do 
    not contact vaginal tissue and that interlabial pads present different 
    risks than reusable menstrual pads, both types of pads still meet the 
    reserved criteria. FDA did not group these types of pads as reserved 
    devices because they had the same risks but has determined both need to 
    undergo premarket review based on their risks independently. FDA agrees 
    that the term the term ``interlabial'' is more appropriate than the 
    term ``intralabial'' and is using the term ``interlabial'' in the final 
    rule and Sec. 884.5435.
        2. Another comment requested clarification of the scope of the 
    classification and exemption of the blood bank centrifuge for in vitro 
    diagnostic use (Sec. 864.9275 (21 CFR 864.9275)). More specifically, 
    the comment asked whether centrifuges used to separate whole blood into 
    its component parts for eventual transfusion to patients are exempt 
    from premarket notification.
        Section 864.9275 applies to the small tabletop centrifuges used to 
    spin down test tubes of blood samples used in immunohematology tests. 
    This classification does not include a centrifuge used to separate or 
    prepare blood components for transfusion, which is classified in class 
    II as an autotransfusion apparatus (21 CFR 868.5830) and is subject to 
    premarket notification requirements.
        3. One comment requested clarification about how the ``Limitations 
    to exemption'' apply to a device labeled for general use, such as 21 
    CFR 862.2300 Colorimeter, photometer, or spectrophotometer for clinical 
    use or 21 CFR 862.2560 Fluorometer for clinical use. Section 862.9(c) 
    states the exemption from 510(k) of the act does not apply if the 
    device is intended, ``for measuring an analyte that serves as a 
    surrogate marker for screening, diagnosis, or monitoring life-
    threatening diseases such as acquired immune deficiency syndrome 
    (AIDS), chronic or active hepatitis, tuberculosis, or myocardial 
    infarction or to monitor therapy.''
        The ``Limitations to exemption'' refer to the device, as labeled. 
    If the device has been labeled as a general purpose device, and was 
    exempt, and it is now to be labeled for a specific indication, such as 
    cytomegalovirus, a new 510(k) must be submitted and cleared before that 
    specific indication can be marketed.
        4. One comment regarding the ``Limitations to exemption'' objected 
    to the revocation of the premarket notification exemption for the 
    cardiopulmonary bypass accessory equipment involving an electrical 
    connection to the patient prior to up-classifying them into class II in 
    order to comply with the performance standard for cables and leads. The 
    comment stated that many of the cardiopulmonary bypass devices did not 
    involve a cable or lead.
        FDA has reviewed the devices that fall under this regulation and 
    agrees that many of the devices do not involve electrical connections 
    to the patient. On August 9, 1999 (64 FR 43114), FDA published a 
    proposed rule to reclassify three devices into class II in order to 
    make them subject to the performance standard for electrode lead wires 
    and patient cables. These three devices are: (1) Cardiopulmonary bypass 
    accessory equipment that involves an electrical connection to the 
    patient, (2) the goniometer device, and (3) the electrode cable. Under 
    this proposal, cardiopulmonary bypass accessory equipment that does not 
    involve an electrical connection to the patient would remain in class I 
    and would be exempt from the premarket notification requirements. 
    Because FDA believes that compliance with the performance standard for 
    electrode lead wires and patient cables would provide adequate 
    assurance of the safety and effectiveness of these devices, the 
    proposal provides that these devices would be exempt from the premarket 
    notification requirements.
        Elsewhere in this issue of the Federal Register, FDA is announcing 
    that it is withdrawing the proposed rules to revoke the exemptions from 
    premarket notification for cardiopulmonary bypass accessory equipment 
    and the electrode cable. Under existing 21 CFR 870.4200 
    (cardiopulmonary bypass accessory equipment) and 21 CFR 890.1175 
    (electrode cable), these devices are exempt from the premarket 
    notification requirements. These exemptions will remain in effect. FDA 
    expects to finalize the August 9, 1999, proposed rule to make these 
    devices class II shortly after the comment period ends on November 8, 
    1999. If the rule is finalized, the devices will be exempt from the 
    premarket notification requirements and all such devices will be 
    subject to the performance standard for electrode lead wires and 
    patient cables, when the second phase of that rule becomes effective on 
    May 9, 2000. FDA believes that there is no reason to make these devices 
    subject to premarket notification requirements for the short period of 
    time between the revocation of the exemption from premarket 
    notification requirements, as proposed in the November 12, 1998, 
    Federal Register, and the reclassification and exemption from premarket 
    notification requirements of these devices, as proposed in the August 
    9, 1999, Federal Register.
        The goniometer device is not a subject of this rule and premarket 
    notification is still required for these devices under existing 21 CFR 
    888.1500, until the August 9, 1999, rule is finalized.
        5. FDA, on its own initiative, is adding all versions of the 
    keratoscope (21 CFR 886.1350) to the list of devices exempt from 
    premarket notification requirements. Previously, only keratoscopes that 
    did not include computer software were exempt from premarket 
    notification. In the Federal Register of February 2, 1998 (63 FR 5387), 
    FDA listed a keratoscope with computer software, as a device that it 
    believed fell under the exemption criteria in section 510(l) of the 
    act. The proposed rule, however, did not include the keratoscope with 
    computer software under those devices FDA proposed to codify as exempt. 
    Subsequent to the issuance of the proposed rule, FDA received an 
    inquiry concerning the exemption status of this device. Upon 
    consideration, FDA does not believe that the keratoscope with computer 
    software is intended for a use that is of substantial importance in 
    preventing impairment of human health or that it presents a potential 
    unreasonable risk of illness or injury and therefore it is exempt from 
    the premarket notification requirements.
        6. FDA, on its own initiative, has made some minor changes in the 
    sections of each classification, which describe the limitations to 
    exemptions from section 510(k) of the act. In these sections, FDA lists 
    certain intended uses or changes that will preclude a device
    
    [[Page 2299]]
    
    from falling within an exemption that is otherwise applicable to a 
    generic class of devices.
        In the final rule, FDA made some nonsubstantive changes in the 
    introductory paragraph that clarify FDA's reasons for the types of 
    limitations listed. In proposed sections of each classification 
    regulation, FDA explained that it listed the limitations because those 
    types of changes were unforeseeable, and, therefore could significantly 
    affect safety and effectiveness. The final rule clarifies that FDA also 
    listed certain types of limitations because any misdiagnosis using 
    devices for the listed intended uses may be associated with high 
    morbidity or mortality.
        In addition, FDA has made minor changes in describing two of the 
    intended uses of in vitro devices that would require a premarket 
    notification. Proposed limitations in paragraph (c)(2) stated that 
    premarket notifications must be submitted when a device is an in vitro 
    device that is intended for use in ``screening or diagnosis of familial 
    and acquired genetic disorders, including inborn errors of 
    metabolism.'' (Emphasis added.) The proposed rule may have been 
    interpreted to require premarket notification for only devices that 
    were used in screening or diagnosis of both familial and acquired 
    genetic disorders.
        FDA intended that devices used in connection with either familial 
    or acquired genetic disorders be subject to premarket notification 
    requirements because misdiagnosis of either of these disorders would be 
    associated with high morbidity or mortality. Accordingly, FDA has 
    amended the final rule in each limitation section of each 
    classification regulation to state that premarket notifications must be 
    submitted when a device is an in vitro device that is intended for use 
    in ``screening or diagnosis of familial or acquired genetic disorders, 
    including inborn errors of metabolism.'' (Emphasis added.)
        Similarly, FDA stated in the proposed limitation in paragraph 
    (c)(7) that it would require premarket notification for in vitro 
    devices intended for detection of antibodies to microorganisms other 
    than immunoglobulin G (IgG) and IgG assays when the results are not 
    qualitative * * *.'' The proposed rule could be interpreted to require 
    premarket notification unless the device were intended for detection of 
    both IgG and IgG assays. FDA is amending the final rule in the 
    limitation in paragraph (c)(7) by replacing the word ``and'' with 
    ``or'' to indicate that if an exempt in vitro device is intended to 
    detect antibodies to either IgG or IgG assays, the device will remain 
    exempt.
        7. FDA, on its own initiative, has added language clarifying the 
    description of exempted devices in Sec. 880.5090 Liquid bandage (21 CFR 
    880.5090), Sec. 886.4070 Powered corneal burr (21 CFR 886.4070), and 
    Sec. 886.4750 Ophthalmic eye shield (21 CFR 886.4750). The proposed 
    classification descriptions state that the devices were exempt from 
    premarket notification requirements when used for certain intended 
    uses. FDA has added language to clarify that the exemption applies only 
    when the device is used exclusively for the intended uses stated in the 
    classification descriptions.
        For example, proposed Sec. 880.5090 Liquid bandage stated: ``When 
    used as a skin protectant, the device is exempt from premarket 
    notification procedures.'' FDA amended final Sec. 880.5090 by adding 
    the word ``only'' to the text to clarify that if the device were 
    intended for a use in addition to protecting skin, it would not qualify 
    for the exemption. Accordingly, final Sec. 880.5090 states: ``When used 
    only as a skin protectant, the device is exempt from premarket 
    notification procedures.'' Similarly, FDA has amended final 
    Secs. 886.4070 Powered corneal burr and 886.4750 Ophthalmic eye shield 
    by adding the word ``only'' to clarify the exemption does not apply 
    when the device is used for intended uses not specifically stated in 
    the regulation.
        8. Also, on its own initiative, FDA is revising the description of 
    the exempted device, rubber dam, in 21 CFR 872.6300(a) to clarify that 
    this device does not include a rubber dam, which is intended for 
    prevention of sexually transmitted diseases during oral sex. Such a 
    device is classified as a condom in 21 CFR 884.5300.
    
    IV. Designation of Devices
    
        The following devices are devices that FDA believes meet the 
    reserved criteria in section 206 of FDAMA and, therefore, FDA is 
    codifying the determination that they remain subject to premarket 
    notification under new section 510(l) of the act:
    
                                    Table 1--Designations of Reserved Class I Devices
    ----------------------------------------------------------------------------------------------------------------
                     21 CFR Section                                           Name of Device
    ----------------------------------------------------------------------------------------------------------------
    862.1065                                         Ammonia test system
    862.1113                                         Bilirubin (total and unbound) in the neonate test system
    862.1310                                         Galactose test system
    862.1410                                         Iron (non-heme) test system
    862.1415                                         Iron-binding capacity test system
    862.1495                                         Magnesium test system
    862.1580                                         Phosphorous (inorganic) test system
    862.1660                                         Quality control material (assayed and unassayed) 1
    862.1680                                         Testosterone test system
    862.1730                                         Free tyrosine test system
    862.1775                                         Uric acid test system
    862.3050                                         Breath-alcohol test system
    862.3110                                         Antimony test system
    862.3120                                         Arsenic test system
    862.3220                                         Carbon monoxide test system
    862.3240                                         Cholinesterase test system
    862.3280                                         Clinical toxicology control material (assayed and unassayed) 1
    862.3600                                         Mercury test system
    862.3750                                         Quinine test system
    862.3850                                         Sulfonamide test system
    864.7040                                         Adenosine triphosphate release assay
    864.8950                                         Russell viper venom reagent
    864.9050                                         Blood bank supplies
    864.9125                                         Vacuum-assisted blood collection system 2
    864.9195                                         Blood mixing devices and blood weighing devices 2
    
    [[Page 2300]]
    
     
    866.2390                                         Transport culture medium
    866.2560                                         Microbial growth monitor 3
    866.2850                                         Automated zone reader
    866.2900                                         Microbiological specimen collection and transport device
    866.3110                                         Campylobacter fetus serological reagents
    866.3120                                         Chlamydia serological reagents
    866.3235                                         Epstein-Barr virus serological reagents
    866.3370                                         Mycobacterium tuberculosis immunofluorescent reagents
    866.3870                                         Trypanosoma spp. serological reagents
    872.3700                                         Dental mercury
    872.4200                                         Dental handpiece and accessories
    872.6250                                         Dental chair and accessories 4
    872.6640                                         Dental operative unit and accessories 5
    872.6710                                         Boiling water sterilizer
    876.5160                                         Urological clamps for males 6
    878.4460                                         Surgeon's glove
    880.5090                                         Liquid bandage 7
    880.5680                                         Pediatric position holder
    880.6250                                         Patient examination glove
    880.6375                                         Patient lubricant
    880.6760                                         Protective restraint
    882.1030                                         Ataxiagraph
    882.1420                                         Electroencephalogram (EEG) signal spectrum analyzer
    882.4060                                         Ventricular cannula 8
    882.4545                                         Shunt system implantation instrument 9
    884.2980(a)                                      Telethermographic system 10
    884.2982(a)                                      Liquid crystal thermographic system 11
    884.5435                                         Unscented menstrual pads (interlabial pads and reusable
                                                      menstrual pads)
    886.4070                                         Powered corneal burr 12
    886.4300                                         Intraocular lens guide 13
    886.4370                                         Keratome
    886.4750                                         Ophthalmic eye shield (when made of other than plastic or
                                                      aluminum)
    888.1500                                         Goniometer
    890.3850                                         Mechanical wheelchair
    890.5710                                         Hot or cold disposable pack 14
    892.1100                                         Scintillation (gamma) camera
    892.1110                                         Positron camera
    ----------------------------------------------------------------------------------------------------------------
    \1\ Meets reserved criteria for all assayed and only the unassayed when used for donor screening.
    \2\ Meets reserved criteria when automated.
    \3\ Meets reserved criteria when automated blood culturing systems.
    \4\ Meets reserved criteria when dental chair with the operative unit.
    \5\ Meets reserved criteria when it is not an accessory to the unit.
    \6\ Meets reserved criteria when devices are for internal use or are used for females.
    \7\ Meets reserved criteria for uses other than as a skin protectant.
    \8\ Meets reserved criteria if not made of surgical grade stainless steel.
    \9\ Meets reserved criteria if not made of surgical grade stainless steel.
    \10\ Meets reserved criteria if an adjunct use system.
    \11\ Meets reserved criteria if nonelectrically powered or AC-powered adjunctive system.
    \12\ Meets reserved criteria if for use other than for removing rust rings.
    \13\ Meets reserved criteria if used as folders or injectors for soft or foldable intraocular lenses (IOL's).
    \14\ Meets reserved criteria if indicated for use on infants.
    
        FDA is amending the regulations to designate the following devices 
    as exempt from premarket notification because FDA believes that they do 
    not meet the reserved criteria under new section 510(l) of the act:
    
                                    Table 2--Designations of Exempted Class I Devices
    ----------------------------------------------------------------------------------------------------------------
                     21 CFR Section                                           Name of Device
    ----------------------------------------------------------------------------------------------------------------
    862.1030                                         Alanine amino transferase (ALT/SGPT) test system
    862.1040                                         Aldolase test system
    862.1060                                         Delta-aminolevulinic acid test system
    862.1075                                         Androstenedione test system
    862.1080                                         Androsterone test system
    862.1095                                         Ascorbic acid test system
    862.1115                                         Urinary bilirubin and its conjugates (nonquantitative) test
                                                      system
    862.1130                                         Blood volume test system
    862.1135                                         C-peptides of proinsulin test system
    862.1165                                         Catecholamines (total) test system
    862.1175                                         Cholesterol (total) test
    862.1180                                         Chymotrypsin test system
    862.1185                                         Compound S (11-deoxycortisol) test system
    862.1195                                         Corticoids test system
    
    [[Page 2301]]
    
     
    862.1200                                         Corticosterone test system
    862.1240                                         Cystine test system
    862.1245                                         Dehydroepiandrosterone (free and sulfate) test system
    862.1250                                         Desoxycorticosterone test system
    862.1260                                         Estradiol test system
    862.1265                                         Estriol test system
    862.1270                                         Estrogens (total, in pregnancy) test system
    862.1275                                         Estrogens (total, nonpregnancy) test system
    862.1280                                         Estrone test system
    862.1285                                         Etiocholanolone test system
    862.1300                                         Follicle-stimulating hormone test system
    862.1325                                         Gastrin test system
    862.1330                                         Globulin test system
    862.1335                                         Glucagon test system
    862.1360                                         Gamma-glutamyl transpeptidase and isoenzymes test system
    862.1370                                         Human growth hormone test system
    862.1375                                         Histidine test system
    862.1385                                         17-Hydroxycorticosteroids (17-ketogenic steroids) test system
    862.1390                                         5-Hydroxyindole acetic acid/serotonin test system
    862.1395                                         17-Hydroxyprogesterone test system
    862.1400                                         Hydroxyproline test system
    862.1405                                         Immunoreactive insulin test system
    862.1430                                         17-Ketosteroids test system
    862.1435                                         Ketones (nonquantitative) test system
    862.1450                                         Lactic acid test system
    862.1460                                         Leucine aminopeptidase test system
    862.1465                                         Lipase test system
    862.1475                                         Lipoprotein test system
    862.1485                                         Luteinizing hormone test system
    862.1500                                         Malic dehydrogenase test system
    862.1505                                         Mucopolysaccharides (nonquantitative) test system
    862.1510                                         Nitrite (nonquantitative) test system
    862.1520                                         5'-Nucleotidase test system
    862.1530                                         Plasma oncometry test system
    862.1535                                         Ornithine carbamyl transferase test system
    862.1540                                         Osmolality test system
    862.1542                                         Oxalate test system
    862.1550                                         Urinary pH (nonquantitative) test system
    862.1560                                         Urinary phenylketones (nonquantitative) test system
    862.1570                                         Phosphohexose isomerase test system
    862.1590                                         Porphobilinogen test system
    862.1595                                         Porphyrins test system
    862.1605                                         Pregnanediol test system
    862.1610                                         Pregnanetriol test system
    862.1615                                         Pregnenolone test system
    862.1620                                         Progesterone test system
    862.1625                                         Prolactin (lactogen) test system
    862.1630                                         Protein (fractionation) test system
    862.1645                                         Urinary protein or albumin (nonquantitative) test system
    862.1650                                         Pyruvate kinase test system
    862.1655                                         Pyruvic acid test system
    862.1660                                         Quality control material (assayed and unassayed) 1
    862.1705                                         Triglyceride test system
    862.1725                                         Trypsin test system
    862.1780                                         Urinary calculi (stones) test system
    862.1785                                         Urinary urobilinogen (nonquantitative) test system
    862.1790                                         Uroporphyrin test system
    862.1795                                         Vanilmandelic acid test system
    862.1805                                         Vitamin A test system
    862.1820                                         Xylose test system
    862.2140                                         Centrifugal chemistry analyzer for clinical use
    862.2150                                         Continuous flow sequential multiple chemistry analyzer for
                                                      clinical use
    862.2160                                         Discrete photometric chemistry analyzer for clinical use
    862.2170                                         Micro chemistry analyzer for clinical use
    862.2250                                         Gas liquid chromatography system for clinical use
    862.2260                                         High pressure liquid chromatography system for clinical use
    862.2270                                         Thin-layer chromatography system for clinical use
    862.2300                                         Colorimeter, photometer, or spectrophotometer for clinical use
    862.2400                                         Densitometer/scanner (integrating, reflectance, TLC, or
                                                      radiochromatogram) for clinical use
    862.2500                                         Enzyme analyzer for clinical use
    862.2540                                         Flame emission photometer for clinical use
    
    [[Page 2302]]
    
     
    862.2560                                         Fluorometer for clinical use
    862.2680                                         Microtitrator for clinical use
    862.2700                                         Nephelometer for clinical use
    862.2730                                         Osmometer for clinical use
    862.2750                                         Pipetting and diluting system for clinical use
    862.2850                                         Atomic absorption spectrophotometer for clinical use
    862.2860                                         Mass spectrometer for clinical use
    862.2900                                         Automated urinalysis system
    862.3280                                         Clinical toxicology control material (assayed and unassayed) 1
    864.2280                                         Cultured animal and human cells
    864.3250                                         Specimen transport and storage container
    864.5240                                         Automated blood cell diluting apparatus
    864.6150                                         Capillary blood collection tube
    864.9125                                         Vacuum-assisted blood collection system 2
    864.9185                                         Blood grouping view box
    864.9195                                         Blood mixing devices and blood weighing devices 2
    864.9225                                         Cell-freezing apparatus and reagents for in vitro diagnostic
                                                      use
    864.9275                                         Blood bank centrifuge for in vitro diagnostic use
    864.9320                                         Copper sulphate solution for specific gravity determinations
    864.9750                                         Heat-sealing device
    866.2660                                         Microorganism differentiation and identification device
    866.3040                                         Aspergillus spp. serological reagents
    866.3140                                         Corynebacterium spp. serological reagents
    866.3145                                         Coxsackievirus serological reagents
    866.3200                                         Echinococcus spp. serological reagents
    866.3240                                         Equine encephalomyelitis virus serological reagents
    866.3355                                         Listeria spp. serological reagents
    866.3360                                         Lymphocytic choriomeningitis virus serological reagents
    866.3375                                         Mycoplasma spp. serological reagents
    866.3380                                         Mumps virus serological reagents
    866.3405                                         Poliovirus serological reagents
    866.3480                                         Respiratory syncytial virus serological reagents
    866.3500                                         Rickettsia serological reagents
    866.3600                                         Schistosoma spp. serological reagents
    866.3680                                         Sporothrix schenckii serological reagents
    866.3740                                         Streptococcus spp. serological reagents
    866.3850                                         Trichinella spiralis serological reagents
    866.5060                                         Prealbumin immunological test system
    866.5065                                         Human allotypic marker immunological test system
    866.5160                                         Beta-globulin immunological test system
    866.5200                                         Carbonic anhydrase B and C immunological test
    866.5330                                         Factor XIII, A, S, immunological test system 3
    866.5400                                         Alpha-globulin immunological test system
    866.5420                                         Alpha-1-glycoproteins immunological test system
    866.5425                                         Alpha-2-glycoproteins immunological test system
    866.5430                                         Beta-2-glycoprotein I immunological test system
    866.5440                                         Beta-2-glycoprotein III immunological test system
    866.5560                                         Lactic dehydrogenase immunological test system
    866.5570                                         Lactoferrin immunological test system
    866.5590                                         Lipoprotein X immunological test system
    866.5715                                         Plasminogen immunological test system
    866.5735                                         Prothrombin immunological test system 4
    866.5765                                         Retinol-binding protein immunological test system
    866.5890                                         Inter-alpha trypsin inhibitor immunological test system
    868.1910                                         Esophageal stethoscope
    868.5620                                         Breathing mouthpiece
    868.5640                                         Medicinal nonventilatory nebulizer (atomizer)
    868.5675                                         Rebreathing device
    868.5700                                         Nonpowered oxygen tent
    868.6810                                         Tracheobronchial suction catheter
    872.3275(a)(1)                                   Dental cement (zinc oxide-eugenol)
    872.3400(b)(1)                                   Karaya and sodium borate with or without acacia denture
                                                      adhesive (less than 12 percent sodium borate by weight)
    872.3540(b)(1)                                   OTC denture cushion or pad 5
    872.6300                                         Rubber dam and accessories 6
    872.6390                                         Dental floss
    874.1070                                         Short increment sensitivity index (SISI) adapter
    874.1100                                         Earphone cushion for audiometric testing
    874.1500                                         Gustometer
    874.1800                                         Air or water caloric stimulator
    874.1925                                         Toynbee diagnostic tube
    874.3300(b)(1)                                   Hearing aid 7
    
    [[Page 2303]]
    
     
    874.3540                                         Prosthesis modification instrument for ossicular replacement
                                                      surgery
    874.4100                                         Epistaxis balloon
    874.4420                                         Ear, nose, and throat manual surgical instrument
    874.5300                                         Ear, nose, and throat examination and treatment unit
    874.5550                                         Powered nasal irrigator
    874.5840                                         Antistammering device
    876.5160                                         Urological clamp for males 8
    876.5210                                         Enema kit
    876.5250(b)(2)                                   Urine collector and accessories 9
    876.5980(b)(2)                                   Gastrointestinal tube and accessories 10
    878.3250                                         External facial fracture fixation appliance
    878.3910                                         Noninflatable extremity splint
    878.3925                                         Plastic surgery kit and accessories
    878.4040                                         Surgical apparel 11
    878.4100                                         Organ bag
    878.4200                                         Introduction/drainage catheter and accessories
    878.4320                                         Removable skin clip
    878.4680                                         Nonpowered, single patient, portable suction apparatus
    878.4760                                         Removable skin staple
    878.4820                                         Surgical instrument motors and accessories/attachments
    878.4960                                         Operating tables and accessories and operating chairs and
                                                      accessories
    880.5090                                         Liquid bandage 12
    880.5270                                         Neonatal eye pad
    880.5420                                         Pressure infusor for an I.V. bag
    882.1200                                         Two-point discriminator
    882.1500                                         Esthesiometer
    882.1750                                         Pinwheel
    882.4060                                         Ventricular cannula 13
    882.4545                                         Shunt system implantation instrument 14
    882.4650                                         Neurosurgical suture needle
    882.4750                                         Skull punch 15
    884.1040                                         Viscometer for cervical mucus
    886.1350                                         Keratoscope
    886.1780                                         Retinoscope 16
    886.1940                                         Tonometer sterilizer
    886.4070                                         Powered corneal burr 17
    886.4300                                         Intraocular lens guide 18
    886.5850                                         Sunglasses (nonprescription)
    890.5180                                         Manual patient rotation bed
    890.5710                                         Hot or cold disposable pack 19
    892.1300                                         Nuclear rectilinear scanner
    892.1320                                         Nuclear uptake probe
    892.1330                                         Nuclear whole body scanner
    892.1350                                         Nuclear scanning bed
    892.1410                                         Nuclear electrocardiograph synchronizer
    892.1890                                         Radiographic film illuminator
    892.1910                                         Radiographic grid
    892.1960                                         Radiographic intensifying screen
    892.1970                                         Radiographic ECG/respirator, synchronizer
    892.2010                                         Medical image storage device
    892.2020                                         Medical image communications device
    892.5650                                         Manual radionuclide applicator system
    892.6500                                         Personnel protective shield
    ----------------------------------------------------------------------------------------------------------------
    \1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
    \2\ Exemption is limited to manual devices.
    \3\ This exemption should not be confused with 21 CFR 864.7290.
    \4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750.
    \5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2).
    \6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted
      diseases through oral sex. Those devices are classified as condoms in 21 CFR 884.5300.
    \7\ Exemption is limited to air-conduction hearing aids.
    \8\ Exemption does not include devices for internal use or devices used for females.
    \9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected
      to an indwelling catheter as described in 21 CFR 876.5250(b)(1).
    \10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in 21 CFR
      876.5980(b)(2). Exemption does not include class II devices as described in Sec.  876.5980(b)(1).
    \11\ Exemption is limited to class I category other than surgical gowns and surgical masks.
    \12\ Exemption is limited to uses as a skin protectant.
    \13\ Exemption is limited to devices made of surgical grade stainless steel.
    \14\ Exemption is limited to devices made of surgical grade stainless steel.
    \15\ Exemption should not be confused with 21 CFR 882.4305.
    \16\ Exemption is limited to class I battery-powered devices.
    \17\ Exemption is limited to rust ring removal.
    
    [[Page 2304]]
    
     
    \18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
    \19\ Exemption does not apply if intended for use on infants
    
    V. Environmental Impact
    
        The agency has determined under 21 CFR 25.30(h) that these actions 
    are of a type that do not individually or cumulatively have a 
    significant effect on the human environment. Therefore, neither an 
    environmental assessment nor an environmental impact statement is 
    required.
    
    VI. Analysis of Impacts
    
        FDA has examined the impacts of the final rule under Executive 
    Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as 
    amended by subtitle D of the Small Business Regulatory Fairness Act of 
    1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
    (Public Law 104-4). Executive Order 12866 directs agencies to assess 
    all costs and benefits of available regulatory alternatives and, when 
    regulation is necessary, to select regulatory approaches that maximize 
    net benefits (including potential economic, environmental, public 
    health and safety and other advantages distributive impacts and 
    equity). The agency believes that this rule is consistent with the 
    regulatory philosophy and principles identified in the Executive Order. 
    In addition, the rule is not a significant regulatory action as defined 
    by the Executive Order and so is not subject to review under the 
    Executive Order.
        The Regulatory Flexibility Act requires, if a rule has a 
    significant impact on a substantial number of small entities, agencies 
    to analyze regulatory options that would minimize any significant 
    impact of a rule on small entities. In most cases, the rule would 
    reduce a regulatory burden by exempting manufacturers of devices 
    subject to the rule from the requirements of premarket notification. 
    FDA is requiring premarket notification for three devices that were 
    previously exempt from premarket notification. These devices are as 
    follows:
    
    A. Ophthalmic Eye Shield (When Made of Other Than Plastic or Aluminum) 
    (Sec. 886.4750).
    
        There are six manufacturers of ophthalmic eye shields other than 
    those made of plastic or aluminum registered with FDA. FDA anticipates 
    that any premarket notifications that are necessary for these devices 
    would be simple because FDA would be primarily interested in 
    information about biocompatibility. FDA estimates that preparation of 
    such a premarket notification would cost no more than $5,000 and that 
    there would be no more than 6 premarket notifications per year for a 
    total annual cost of $30,000.
        Six manufacturers are not a substantial number of entities. Based 
    on data compiled by the Small Business Administration, optical goods 
    firms with fewer than 500 employees have annual receipts of $1,524,000. 
    Therefore, the cost per firm of complying with this regulation ($5,000) 
    does not have a significant impact on these small entities.
    
    B. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System 
    (Sec. 862.3850).
    
        At this time, there are no firms registered for manufacture of 
    these devices.
        In light of the previous discussion, under the Regulatory 
    Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final 
    rule will not have a significant economic impact on a substantial 
    number of small entities. The rule also does not trigger the 
    requirement for a written statement under section 202(a) of the 
    Unfunded Mandates Reform Act because it does not impose a mandate that 
    results in an expenditure of $100 million or more by State, local, or 
    tribal governments in the aggregate, or by the private sector, in any 
    one year.
    
    VII. Paperwork Reduction Act of 1995
    
        FDA concludes that this rule contains no collections of 
    information. Therefore, clearance by the Office of Management and 
    Budget under the Paperwork Reduction Act of 1995 is not required.
    
    List of Subjects
    
    21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 
    890
    
        Medical devices.
    
    21 CFR Part 864
    
        Biologics, Blood, Laboratories, Medical devices, Packaging and 
    containers.
    
    21 CFR Part 866
    
        Biologics, Laboratories, Medical devices.
    
    21 CFR Part 886
    
        Medical devices, Ophthalmic goods and services.
    
    21 CFR Part 892
    
        Medical devices, Radiation protection, X-rays.
        Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
    authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
    862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 
    890, and 892 are amended as follows:
    
    PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
    
        1. The authority citation for 21 CFR part 862 continues to read as 
    follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
        2. Section 862.9 is revised to read as follows:
    
    
    Sec. 862.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
        The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
    
    [[Page 2305]]
    
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
        (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
        (9) For near patient testing (point of care).
        3. Section 862.1030 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1030  Alanine amino transferase (ALT/SGPT) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        4. Section 862.1040 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1040  Aldolase test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        5. Section 862.1060 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1060  Delta-aminolevulinic acid test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from premarket notification procedures in subpart E of part 807 
    of this chapter subject to Sec. 862.9.
        6. Section 862.1075 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1075  Androstenedione test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        7. Section 862.1080 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1080  Androsterone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        8. Section 862.1095 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1095  Ascorbic acid test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        9. Section 862.1115 is amended by revising paragraph (b) to read as 
    follows:
    
    Sec. 862.1115  Urinary bilirubin and its conjugates (nonquantitative) 
    test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        10. Section 862.1130 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1130  Blood volume test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        11. Section 862.1135 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1135  C-peptides of proinsulin test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        12. Section 862.1165 is amended by revising paragraph (b) to read 
    follows:
    
    Sec. 862.1165  Catecholamines (total) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        13. Section 862.1175 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1175  Cholesterol (total) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        14. Section 862.1180 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1180  Chymotrypsin test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        15. Section 862.1185 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1185  Compound S (11-deoxycortisol) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         16. Section 862.1195 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1195  Corticoids test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        17. Section 862.1200 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1200  Corticosterone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        18. Section 862.1240 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1240  Cystine test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        19. Section 862.1245 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1245  Dehydroepiandrosterone (free and sulfate) test system.
    
    * * * * *
    
    [[Page 2306]]
    
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        20. Section 862.1250 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1250  Desoxycorticosterone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        21. Section 862.1260 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1260  Estradiol test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        22. Section 862.1265 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1265  Estriol test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        23. Section 862.1270 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1270  Estrogens (total, in pregnancy) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        24. Section 862.1275 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1275  Estrogens (total, nonpregnancy) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        25. Section 862.1280 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1280  Estrone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        26. Section 862.1285 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1285  Etiocholanolone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        27. Section 862.1300 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1300  Follicle-stimulating hormone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        28. Section 862.1325 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1325  Gastrin test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        29. Section 862.1330 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1330  Globulin test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        30. Section 862.1335 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1335  Glucagon test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        31. Section 862.1360 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1360  Gamma-glutamyl transpeptidase and isoenzymes test 
    system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        32. Section 862.1370 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1370  Human growth hormone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        33. Section 862.1375 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1375  Histidine test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        34. Section 862.1385 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1385  17-Hydroxycorticosteroids (17-ketogenic steroids) test 
    system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        35. Section 862.1390 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1390  5-Hydroxyindole acetic acid/serotonin test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        36. Section 862.1395 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1395  17-Hydroxyprogesterone test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        37. Section 862.1400 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1400  Hydroxyproline test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
        38. Section 862.1405 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1405  Immunoreactive insulin test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the
    
    [[Page 2307]]
    
    premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 862.9.
        39. Section 862.1430 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1430  17-Ketosteroids test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         40. Section 862.1435 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1435  Ketones (nonquantitative) test system.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         41. Section 862.1450 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1450  Lactic acid test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         42. Section 862.1460 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1460  Leucine aminopeptidase test system.
    
    * * * * *
        (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         43. Section 862.1465 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1465  Lipase test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         44. Section 862.1475 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1475  Lipoprotein test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         45. Section 862.1485 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1485  Luteinizing hormone test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         46. Section 862.1500 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1500  Malic dehydrogenase test system.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         47. Section 862.1505 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1505  Mucopolysaccharides (nonquantitative) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         48. Section 862.1510 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1510  Nitrite (nonquantitative) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         49. Section 862.1520 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 862.1520  5'-Nucleotidase test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         50. Section 862.1530 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1530  Plasma oncometry test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         51. Section 862.1535 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1535  Ornithine carbamyl transferase test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         52. Section 862.1540 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1540  Osmolality test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         53. Section 862.1542 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1542  Oxalate test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         54. Section 862.1550 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1550  Urinary pH (nonquantitative) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         55. Section 862.1560 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1560  Urinary phenylketones (nonquantitative) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         56. Section 862.1570 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1570  Phosphohexose isomerase test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         57. Section 862.1590 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1590  Porphobilinogen test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         58. Section 862.1595 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1595  Porphyrins test system.
    
    * * * * *
    
    [[Page 2308]]
    
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         59. Section 862.1605 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1605  Pregnanediol test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         60. Section 862.1610 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1610  Pregnanetriol test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         61. Section 862.1615 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1615  Pregnenolone test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         62. Section 862.1620 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1620  Progesterone test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         63. Section 862.1625 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec.  862.1625  Prolactin (lactogen) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         64. Section 862.1630 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1630  Protein (fractionation) test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         65. Section 862.1645 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1645  Urinary protein or albumin (nonquantitative) test 
    system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         66. Section 862.1650 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1650  Pyruvate kinase test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         67. Section 862.1655 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1655  Pyruvic acid test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         68. Section 862.1660 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1660  Quality control material (assayed and unassayed).
    
    * * * * *
         (b) Classification. Class I (general controls). Except when used 
    in donor screening tests, unassayed material is exempt from the 
    premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 862.9.
         69. Section 862.1705 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1705  Triglyceride test system.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         70. Section 862.1725 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1725  Trypsin test system.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         71. Section 862.1780 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1780  Urinary calculi (stones) test system.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         72. Section 862.1785 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1785  Urinary urobilinogen (nonquantitative) test system.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         73. Section 862.1790 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1790  Uroporphyrin test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         74. Section 862.1795 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1795  Vanilmandelic acid test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         75. Section 862.1805 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1805  Vitamin A test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         76. Section 862.1820 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.1820  Xylose test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         77. Section 862.2140 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2140   Centrifugal chemistry analyzer for clinical use.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         78. Section 862.2150 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2150  Continuous flow sequential multiple chemistry analyzer 
    for clinical use.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the
    
    [[Page 2309]]
    
    premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 862.9.
         79. Section 862.2160 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2160  Discrete photometric chemistry analyzer for clinical 
    use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         80. Section 862.2170 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2170  Micro chemistry analyzer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         81. Section 862.2250 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2250  Gas liquid chromatography system for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         82. Section 862.2260 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2260   High pressure liquid chromatography system for clinical 
    use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         83. Section 862.2270 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2270  Thin-layer chromatography system for clinical use.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9. Particular components of TLC 
    systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, 
    TLC developing tanks, and TLC ultraviolet light, are exempt from the 
    current good manufacturing practice regulations in part 820 of this 
    chapter, with the exception of Sec. 820.180 of this chapter, with 
    respect to general requirements concerning records, and Sec. 820.198 of 
    this chapter, with respect to complaint files.
         84. Section 862.2300 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2300  Colorimeter, photometer, or spectrophotometer for 
    clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         85. Section 862.2400 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2400  Densitometer/scanner (integrating, reflectance, TLC, or 
    radiochromatogram) for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         86. Section 862.2500 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2500  Enzyme analyzer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         87. Section 862.2540 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2540  Flame emission photometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         88. Section 862.2560 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2560  Fluorometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         89. Section 862.2680 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2680  Microtitrator for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         90. Section 862.2700 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2700  Nephelometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         91. Section 862.2730 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2730   Osmometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         92. Section 862.2750 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2750  Pipetting and diluting system for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         93. Section 862.2850 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2850  Atomic absorption spectrophotometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         94. Section 862.2860 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2860  Mass spectrometer for clinical use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         95. Section 862.2900 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.2900  Automated urinalysis system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 862.9.
         96. Section 862.3280 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.3280  Clinical toxicology control material.
    
    * * * * *
         (b) Classification. Class I (general controls). Except when used 
    in donor screening, unassayed material is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 862.9.
         97. Section 862.3750 is amended by revising paragraph (b) to read 
    as follows:
    
    [[Page 2310]]
    
    Sec. 862.3750  Quinine test system.
    
    * * * * *
         (b) Classification. Class I.
         98. Section 862.3850 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 862.3850  Sulfonamide test system.
    
    * * * * *
         (b) Classification. Class I.
    
    PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
    
         99. The authority citation for 21 CFR part 864 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        100. Section 864.9 is revised to read as follows:
    
    
    Sec. 864.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
         (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
         (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
         (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
         (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
         (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
         (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
        101. Section 864.2280 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.2280  Cultured animal and human cells.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         102. Section 864.3250 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.3250  Specimen transport and storage container.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         103. Section 864.5240 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.5240  Automated blood cell diluting apparatus.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         104. Section 864.6150 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.6150  Capillary blood collection tube.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         105. Section 864.9125 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9125  Vacuum-assisted blood collection system.
    
    * * * * *
         (b) Classification. Class I (general controls). The manual device 
    is exempt from the premarket notification procedures in subpart E of 
    part 807 of this chapter subject to Sec. 864.9.
         106. Section 864.9185 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9185  Blood grouping view box.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         107. Section 864.9195 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9195  Blood mixing devices and blood weighing devices.
    
    * * * * *
         (b) Classification. Class I (general controls). The manual device 
    is exempt from the premarket notification procedures in subpart E of 
    part 807 of this chapter subject to Sec. 864.9.
         108. Section 864.9225 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9225  Cell-freezing apparatus and reagents for in vitro 
    diagnostic use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         109. Section 864.9275 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9275  Blood bank centrifuge for in vitro diagnostic use.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         110. Section 864.9320 is amended by revising paragraph (b) to read 
    as follows:
    
    [[Page 2311]]
    
    Sec. 864.9320  Copper sulfate solution for specific gravity 
    determinations.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
         111. Section 864.9750 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 864.9750  Heat-sealing device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 864.9.
    
    PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
    
         112. The authority citation for 21 CFR part 866 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        113. Section 866.9 is revised to read as follows:
    
    
    Sec. 866.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
         (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
         (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
         (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
         (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
         (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
        (9) For near patient testing (point of care).
         114. Section 866.2660 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.2660  Microorganism differentiation and identification device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         115. Section 866.3040 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3040  Aspergillus spp. serological reagents.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         116. Section 866.3140 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3140  Corynebacterium spp. serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         117. Section 866.3145 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3145  Coxsackievirus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         118. Section 866.3200 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3200  Echinococcus spp. serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         119. Section 866.3240 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3240  Equine encephalomyelitis virus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         120. Section 866.3355 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3355  Listeria spp. serological reagents.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         121. Section 866.3360 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3360  Lymphocytic choriomeningitis virus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         122. Section 866.3375 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3375  Mycoplasma spp. serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         123. Section 866.3380 is amended by revising paragraph (b) to read 
    as follows:
    
    [[Page 2312]]
    
    Sec. 866.3380  Mumps virus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         124. Section 866.3405 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3405  Poliovirus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         125. Section 866.3480 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3480  Respiratory syncytial virus serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         126. Section 866.3500 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3500  Rickettsia serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         127. Section 866.3600 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3600  Schistosoma spp. serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         128. Section 866.3680 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3680  Sporothrix schenckii serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
        129. Section 866.3740 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3740  Streptococcus spp. serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         130. Section 866.3850 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.3850  Trichinella spiralis serological reagents.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         131. Section 866.5060 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5060  Prealbumin immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         132. Section 866.5065 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5065  Human allotypic marker immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         133. Section 866.5160 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5160  Beta-globulin immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         134. Section 866.5200 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5200  Carbonic anhydrase B and C immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         135. Section 866.5330 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5330  Factor XIII, A, S, immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9. This exemption does not 
    apply to factor deficiency tests classified under Sec. 864.7290 of this 
    chapter.
        136. Section 866.5400 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5400  Alpha-globulin immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         137. Section 866.5420 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5420  Alpha-1-glycoproteins immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         138. Section 866.5425 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 866.5425  Alpha-2-glycoproteins immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         139. Section 866.5430 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5430  Beta-2-glycoprotein I immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         140. Section 866.5440 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5440  Beta-2-glycoprotein III immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         141. Section 866.5560 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5560  Lactic dehydrogenase immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         142. Section 866.5570 is amended by revising paragraph (b) to read 
    as follows:
    
    [[Page 2313]]
    
    Sec. 866.5570  Lactoferrin immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         143. Section 866.5590 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5590  Lipoprotein X immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         144. Section 866.5715 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5715  Plasminogen immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         145. Section 866.5735 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5735  Prothrombin immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9. This exemption does not 
    apply to multipurpose systems for in vitro coagulation studies 
    classified under Sec. 864.5425 of this chapter or prothrombin time 
    tests classified under Sec. 864.7750 of this chapter.
         146. Section 866.5765 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5765  Retinol-binding protein immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
         147. Section 866.5890 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 866.5890  Inter-alpha trypsin inhibitor immunological test system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 866.9.
    
    PART 868--ANESTHESIOLOGY DEVICES
    
         148. The authority citation for 21 CFR part 868 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        149. Section 868.9 is revised to read as follows:
    
    
    Sec. 868.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         150. Section 868.1910 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.1910  Esophageal stethoscope.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 868.9.
         151. Section 868.5620 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.5620  Breathing mouthpiece.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 868.9.
         152. Section 868.5640 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.5640  Medicinal nonventilatory nebulizer (atomizer).
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 868.9.
         153. Section 868.5675 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.5675  Rebreathing device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 868.9.
         154. Section 868.5700 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.5700  Nonpowered oxygen tent.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in
    
    [[Page 2314]]
    
    subpart E of part 807 of this chapter subject to Sec. 868.9.
         155. Section 868.6810 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 868.6810  Tracheobronchial suction catheter.
    
    * * * * *
         (b)  Classification. Class 1 (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 868.9.
    
     PART 870--CARDIOVASCULAR DEVICES
    
         156. The authority citation for 21 CFR part 870 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        157. Section 870.9 is revised to read as follows:
    
    
    Sec. 870.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
         (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
    
    PART 872--DENTAL DEVICES
    
         158. The authority citation for 21 CFR part 872 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         159. Section 872.9 is revised to read as follows:
    
    
    Sec. 872.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
         (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
         (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         160. Section 872.3275 is amended by revising paragraph (a)(2) to 
    read as follows:
    
    
    Sec. 872.3275  Dental cement.
    
        (a) * * *
         (2) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 872.9.
    * * * * *
    
    [[Page 2315]]
    
         161. Section 872.3400 is amended by revising paragraph (b)(1) to 
    read as follows:
    
    
    Sec. 872.3400  Karaya and sodium borate with or without acacia denture 
    adhesive.
    
    * * * * *
         (b) Classification. (1) Class I (general controls) if the device 
    contains less than 12 percent by weight of sodium borate. The class I 
    device is exempt from the premarket notification procedures in subpart 
    E of part 807 of this chapter subject to Sec. 872.9.
    * * * * *
         162. Section 872.3540 is amended by revising paragraph (b)(1) to 
    read as follows:
    
    
    Sec. 872.3540  OTC denture cushion or pad.
    
    * * * * *
         (b) Classification. (1) Class I if the device is made of wax-
    impregnated cotton cloth that the patient applies to the base or inner 
    surface of a denture before inserting the denture into the mouth. The 
    device is intended to be discarded following 1 day's use. The class I 
    device is exempt from the premarket notification procedures in subpart 
    E of part 807 of this chapter subject to Sec. 872.9.
    * * * * *
         163. Section 872.6300 is revised to read as follows:
    
    
    Sec. 872.6300  Rubber dam and accessories.
    
         (a) Identification. A rubber dam and accessories is a device 
    composed of a thin sheet of latex with a hole in the center intended to 
    isolate a tooth from fluids in the mouth during dental procedures, such 
    as filling a cavity preparation. The device is stretched around a tooth 
    by inserting a tooth through a hole in the center. The device includes 
    the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a 
    rubber dam clamp. This classification does not include devices intended 
    for use in preventing transmission of sexually transmitted diseases 
    through oral sex; those devices are classified as condoms in 
    Sec. 884.5300 of this chapter.
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 872.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         164. Section 872.6390 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 872.6390  Dental floss.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 872.9.
         165. Section 872.6640 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 872.6640  Dental operative unit and accessories.
    
    * * * * *
         (b) Classification. Class I (general controls). Except for dental 
    operative unit, accessories are exempt from premarket notification 
    procedures in subpart E of part 807 of this chapter subject to 
    Sec. 872.9.
    
    PART 874--EAR, NOSE, AND THROAT DEVICES
    
         166. The authority citation for 21 CFR part 874 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         167. Section 874.9 is revised to read as follows:
    
    
    Sec. 874.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
         (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         168. Section 874.1070 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.1070  Short increment sensitivity index (SISI) adapter.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         169. Section 874.1100 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.1100  Earphone cushion for audiometric testing.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         170. Section 874.1500 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.1500  Gustometer.
    
    * * * * *
    
    [[Page 2316]]
    
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         171. Section 874.1800 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.1800  Air or water caloric stimulator.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         172. Section 874.1925 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.1925  Toynbee diagnostic tube.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         173. Section 874.3300 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.3300  Hearing Aid.
    
    * * * * *
         (b) Classification. (1) Class I (general controls) for the air-
    conduction hearing aid. The air-conduction hearing aid is exempt from 
    the premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 874.9.
        (2) Class II for the bone-conduction hearing aid.
         174. Section 874.3540 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.3540  Prosthesis modification instrument for ossicular 
    replacement surgery.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         175. Section 874.4100 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.4100  Epistaxis balloon.
    
    * * * * *
        (b) Classification Class I (general controls). The device is exempt 
    from the premarket notification procedures in subpart E of part 807 of 
    this chapter subject to Sec. 874.9.
         176. Section 874.4420 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.4420  Ear, nose, and throat manual surgical instrument.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         177. Section 874.5300 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.5300  Ear, nose, and throat examination and treatment unit.
    
    * * * * *
        (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         178. Section 874.5550 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.5550  Powered nasal irrigator.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
         179. Section 874.5840 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 874.5840  Antistammering device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 874.9.
    
    PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
    
         180. The authority citation for 21 CFR part 876 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
    
         181. Section 876.9 is revised to read as follows:
    
    
    Sec. 876.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
         (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
         (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
         (5) For use in diabetes management;
         (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
    
    [[Page 2317]]
    
        (9) For near patient testing (point of care).
         182. Section 876.5160 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 876.5160  Urological clamp for males.
    
    * * * * *
         (b) Classification. Class I (general controls). Except when 
    intended for internal use or use on females, the device is exempt from 
    the premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 876.9.
         183. Section 876.5210 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 876.5210  Enema kit.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 876.9. The device is exempt from 
    the current good manufacturing practice regulations in part 820 of this 
    chapter, with the exception of Sec. 820.180 of this chapter, with 
    respect to general requirements concerning records, and Sec. 820.198 of 
    this chapter, with respect to complaint files.
         184. Section 876.5250 is amended by revising paragraph (b)(2) to 
    read as follows:
    
    
    Sec. 876.5250  Urine collector and accessories.
    
    * * * * *
         (b) * * *
         (2) Class I (general controls) for a urine collector and 
    accessories not intended to be connected to an indwelling catheter. The 
    class I device is exempt from the premarket notification procedures in 
    subpart E of part 807 of this chapter subject to Sec. 876.9. If the 
    device is not labeled or otherwise represented as sterile, it is exempt 
    from the current good manufacturing practice regulations in part 820 of 
    this chapter, with the exception of Sec. 820.180 of this chapter, with 
    respect to the general requirements concerning records, and 
    Sec. 820.198 of this chapter, with respect to complaint files.
         185. Section 876.5980 is amended by revising paragraph (b)(2) to 
    read as follows:
    
    
    Sec. 876.5980  Gastrointestinal tube and accessories.
    
    * * * * *
         (b) * * *
         (2) Class I (general controls) for the dissolvable nasogastric 
    feed tube guide for the nasogastric tube. The class I device is exempt 
    from the premarket notification procedures in subpart E of part 807 of 
    this chapter subject to Sec. 876.9.
    
    PART 878--GENERAL AND PLASTIC SURGERY DEVICES
    
         186. The authority citation for 21 CFR part 878 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
    
         187. Section 878.9 is revised to read as follows:
    
    
    Sec. 878.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
         (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
        (9) For near patient testing (point of care).
        188. Section 878.3250 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.3250  External facial fracture fixation appliance.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         189. Section 878.3910 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.3910  Noninflatable extremity splint.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         190. Section 878.3925 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.3925  Plastic surgery kit and accessories.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         191. Section 878.4040 is amended by revising paragraph (b) to read 
    as follows:
    
    [[Page 2318]]
    
    Sec. 878.4040  Surgical apparel.
    
    * * * * *
         (b) Classification. (1) Class II (special controls) for surgical 
    gowns and surgical masks.
         (2) Class I (general controls) for surgical apparel other than 
    surgical gowns and surgical masks. The class I device is exempt from 
    the premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 878.9.
         192. Section 878.4100 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4100  Organ bag.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         193. Section 878.4200 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4200  Introduction/drainage catheter and accessories.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         194. Section 878.4320 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4320  Removable skin clip.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         195. Section 878.4680 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4680  Nonpowered, single patient, portable suction apparatus.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         196. Section 878.4760 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4760  Removable skin staple.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         197. Section 878.4820 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4820  Surgical instrument motors and accessories/attachments.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
         198. Section 878.4960 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 878.4960  Operating tables and accessories and operating chairs 
    and accessories.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 878.9.
    
    PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
    
         199. The authority citation for 21 CFR part 880 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         200. Section 880.9 is revised to read as follows:
    
    
    Sec. 880.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
         (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
         (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         201. Section 880.5090 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 880.5090  Liquid bandage.
    
    * * * * *
        (b) Classification. Class I (general controls). When used only as a 
    skin protectant, the device is exempt from the premarket notification 
    procedures in subpart E of part 807 of this chapter subject to 
    Sec. 880.9.
         202. Section 880.5270 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 880.5270  Neonatal eye pad.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 880.9. If the device is not labeled 
    or otherwise represented as sterile, it is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
    
    [[Page 2319]]
    
        203. Section 880.5420 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 880.5420  Pressure infusor for an I.V. bag.
    
    * * * * *
        (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 880.9.
    
    PART 882--NEUROLOGICAL DEVICES
    
         204. The authority citation for 21 CFR part 882 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         205. Section 882.9 is revised to read as follows:
    
    
    Sec. 882.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
         (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         206. Section 882.1200 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.1200  Two-point discriminator.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 882.9. The device is also exempt 
    from the current good manufacturing practice regulations in part 820 of 
    this chapter, with the exception of Sec. 820.180 of this chapter, with 
    respect to general requirements concerning records, and Sec. 820.198 of 
    this chapter, with respect to complaint files.
        207. Section 882.1500 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.1500  Esthesiometer.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 882.9. The device is also exempt 
    from the current good manufacturing practice regulations in part 820 of 
    this chapter, with the exception of Sec. 820.180 of this chapter, with 
    respect to general requirements concerning records, and Sec. 820.198 of 
    this chapter, with respect to complaint files.
         208. Section 882.1750 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.1750  Pinwheel.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 882.9.
         209. Section 882.4060 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.4060  Ventricular cannula.
    
    * * * * *
         (b) Classification. Class I (general controls). When made only of 
    surgical grade stainless steel, the device is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 882.9.
         210. Section 882.4545 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.4545  Shunt system implantation instrument.
    
    * * * * *
         (b) Classification. Class I (general controls). When made only of 
    surgical grade stainless steel, the device is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 882.9.
         211. Section 882.4650 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.4650  Neurosurgical suture needle.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 882.9.
         212. Section 882.4750 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 882.4750  Skull punch.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 882.9. This exemption does not 
    apply to powered compound cranial drills, burrs, trephines, and their 
    accessories classified under Sec. 882.4305.
    
    PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
    
         213. The authority citation for 21 CFR part 884 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         214. Section 884.9 is revised to read as follows:
    
    
    Sec. 884.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I
    
    [[Page 2320]]
    
    or II device is only to the extent that the device has existing or 
    reasonably foreseeable characteristics of commercially distributed 
    devices within that generic type or, in the case of in vitro diagnostic 
    devices, only to the extent that misdiagnosis as a result of using the 
    device would not be associated with high morbidity or mortality. 
    Accordingly, manufacturers of any commercially distributed class I or 
    II device for which FDA has granted an exemption from the requirement 
    of premarket notification must still submit a premarket notification to 
    FDA before introducing or delivering for introduction into interstate 
    commerce for commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
        (9) For near patient testing (point of care).
         215. Section 884.1040 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 884.1040  Viscometer for cervical mucus.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 884.9.
    
    
    Sec. 884.5435  [Amended]
    
        216. Section 884.5435 Unscented menstrual pad is amended in the 
    last sentence of paragraph (b) by removing the word ``intralabial'' and 
    adding in its place the word ``interlabial''.
    
    PART 886--OPHTHALMIC DEVICES
    
        217. The authority citation for 21 CFR part 886 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         218. Section 886.9 is revised to read as follows:
    
    
    Sec. 886.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
         (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
         (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
         (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
         (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
        219. Section 886.1350 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.1350  Keratoscope.
    
    * * * * *
        (b) The device is exempt from the premarket notification procedures 
    in subpart E of part 807 of this chapter subject to Sec. 886.9. The 
    battery-powered device is exempt from the current good manufacturing 
    practice regulations in part 820 of this chapter, with the exception of 
    Sec. 820.180 of this chapter, with respect to general requirements 
    concerning records, and Sec. 820.198 of this chapter, with respect to 
    complaint files
        220. Section 886.1780 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.1780  Retinoscope.
    
    * * * * *
         (b) Classification. (1) Class II (special controls) for the AC-
    powered device.
         (2) Class I (general controls) for the battery-powered device. The 
    class I
    
    [[Page 2321]]
    
    battery-powered device is exempt from the premarket notification 
    procedures in subpart E of part 807 of this chapter subject to 
    Sec. 886.9. The battery-powered device is exempt from the current good 
    manufacturing practice regulations in part 820 of this chapter, with 
    the exception of Sec. 820.180 of this chapter, with respect to general 
    requirements concerning records, and Sec. 820.198 of this chapter, with 
    respect to complaint files.
         221. Section 886.1940 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.1940  Tonometer sterilizer.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 886.9.
         222. Section 886.4070 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.4070  Powered corneal burr.
    
    * * * * *
         (b) Classification. Class I (general controls). When intended only 
    for rust ring removal, the device is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 886.9.
         223. Section 886.4300 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.4300  Intraocular lens guide.
    
    * * * * *
         (b) Classification. Class I (general controls). Except when used 
    as folders or injectors for soft or foldable intraocular lenses, the 
    device is exempt from the premarket notification procedures in subpart 
    E of part 807 of this chapter subject to Sec. 886.9.
         224. Section 886.4750 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.4750  Ophthalmic eye shield.
    
    * * * * *
         (b) Classification. Class I (general controls). When made only of 
    plastic or aluminum, the device is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 886.9. When made only of plastic or aluminum, the 
    devices are exempt from the current good manufacturing practice 
    regulations in part 820 of this chapter, with the exception of 
    Sec. 820.180 of this chapter, with respect to general requirements 
    concerning records, and Sec. 820.198 of this chapter, with respect to 
    complaint files.
         225. Section 886.5850 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 886.5850  Sunglasses (nonprescription).
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 886.9.
    
    PART 888--ORTHOPEDIC DEVICES
    
         226. The authority citation for 21 CFR part 888 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        227. Section 888.9 is revised to read as follows:
    
    
    Sec. 888.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
         (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
         (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
    
    PART 890--PHYSICAL MEDICINE DEVICES
    
         228. The authority citation for 21 CFR part 890 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         229. Section 890.9 is revised to read as follows:
    
    
    Sec. 890.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
        (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical
    
    [[Page 2322]]
    
    purpose, or the device is intended for lay use where the former 
    intended use was by health care professionals only;
        (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
         (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         230. Section 890.5180 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 890.5180  Manual patient rotation bed.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 890.9.
         231. Section 890.5710 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 890.5710  Hot or cold disposable pack.
    
    * * * * *
         (b) Classification. Class I (general controls). Except when 
    intended for use on infants, the device is exempt from the premarket 
    notification procedures in subpart E of part 807 of this chapter 
    subject to Sec. 890.9.
    
    PART 892--RADIOLOGY DEVICES
    
         232. The authority citation for 21 CFR part 892 continues to read 
    as follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
         233. Section 892.9 is revised to read as follows:
    
    
    Sec. 892.9  Limitations of exemptions from section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act (the act).
    
         The exemption from the requirement of premarket notification 
    (section 510(k) of the act) for a generic type of class I or II device 
    is only to the extent that the device has existing or reasonably 
    foreseeable characteristics of commercially distributed devices within 
    that generic type or, in the case of in vitro diagnostic devices, only 
    to the extent that misdiagnosis as a result of using the device would 
    not be associated with high morbidity or mortality. Accordingly, 
    manufacturers of any commercially distributed class I or II device for 
    which FDA has granted an exemption from the requirement of premarket 
    notification must still submit a premarket notification to FDA before 
    introducing or delivering for introduction into interstate commerce for 
    commercial distribution the device when:
         (a) The device is intended for a use different from the intended 
    use of a legally marketed device in that generic type of device; e.g., 
    the device is intended for a different medical purpose, or the device 
    is intended for lay use where the former intended use was by health 
    care professionals only;
         (b) The modified device operates using a different fundamental 
    scientific technology than a legally marketed device in that generic 
    type of device; e.g., a surgical instrument cuts tissue with a laser 
    beam rather than with a sharpened metal blade, or an in vitro 
    diagnostic device detects or identifies infectious agents by using 
    deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
    technology rather than culture or immunoassay technology; or
        (c) The device is an in vitro device that is intended:
        (1) For use in the diagnosis, monitoring, or screening of 
    neoplastic diseases with the exception of immunohistochemical devices;
        (2) For use in screening or diagnosis of familial or acquired 
    genetic disorders, including inborn errors of metabolism;
        (3) For measuring an analyte that serves as a surrogate marker for 
    screening, diagnosis, or monitoring life-threatening diseases such as 
    acquired immune deficiency syndrome (AIDS), chronic or active 
    hepatitis, tuberculosis, or myocardial infarction or to monitor 
    therapy;
         (4) For assessing the risk of cardiovascular diseases;
        (5) For use in diabetes management;
        (6) For identifying or inferring the identity of a microorganism 
    directly from clinical material;
        (7) For detection of antibodies to microorganisms other than 
    immunoglobulin G (IgG) or IgG assays when the results are not 
    qualitative, or are used to determine immunity, or the assay is 
    intended for use in matrices other than serum or plasma;
        (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
    chapter; and
         (9) For near patient testing (point of care).
         234. Section 892.1300 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1300  Nuclear rectilinear scanner.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         235. Section 892.1320 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1320  Nuclear uptake probe.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         236. Section 892.1330 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1330  Nuclear whole body scanner.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         237. Section 892.1350 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1350  Nuclear scanning bed.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         238. Section 892.1410 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1410  Nuclear electrocardiograph synchronizer.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the
    
    [[Page 2323]]
    
    premarket notification procedures in subpart E of part 807 of this 
    chapter subject to Sec. 892.9.
         239. Section 892.1890 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1890  Radiographic film illuminator.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         240. Section 892.1910 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1910  Radiographic grid.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         241. Section 892.1960 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1960  Radiographic intensifying screen.
    
    * * * * *
         (b)  Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         242. Section 892.1970 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.1970  Radiographic ECG/respirator synchronizer.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         243. Section 892.2010 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.2010  Medical image storage device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         244. Section 892.2020 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.2020  Medical image communications device.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         245. Section 892.5650 is amended by revising paragraph (b) to read 
    as follows:
    
    Sec. 892.5650  Manual radionuclide applicator system.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
         246. Section 892.6500 is amended by revising paragraph (b) to read 
    as follows:
    
    
    Sec. 892.6500  Personnel protective shield.
    
    * * * * *
         (b) Classification. Class I (general controls). The device is 
    exempt from the premarket notification procedures in subpart E of part 
    807 of this chapter subject to Sec. 892.9.
    
        Dated: December 22, 1999.
    Linda S. Kahan,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 00-884 Filed 1-13-00; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
2/14/2000
Published:
01/14/2000
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
00-884
Dates:
This regulation is effective February 14, 2000.
Pages:
2296-2323 (28 pages)
Docket Numbers:
Docket No. 98N-0009
PDF File:
00-884.pdf
CFR: (233)
21 CFR 864.9185
21 CFR 864.9195
21 CFR 864.9225
21 CFR 864.9275
21 CFR 864.9320
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