98-29569. Dental Devices; Classification of Sulfide Detection Device  

  • [Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
    [Rules and Regulations]
    [Pages 59715-59717]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-29569]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 872
    
    [Docket No. 98P-0731]
    
    
    Dental Devices; Classification of Sulfide Detection Device
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule.
    
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    [[Page 59716]]
    
    SUMMARY: The Food and Drug Administration (FDA) is classifying the 
    sulfide detection device into class II (special controls). The special 
    controls that will apply to the sulfide detection device are 
    restriction to prescription use, conformance with recognized standards 
    relating to biocompatibility, electrical safety and sterility, 
    submission of performance data from analytical and clinical studies 
    demonstrating device effectiveness and adherence to specific labeling 
    requirements. The agency is taking this action in response to a 
    petition submitted under the Federal Food, Drug, and Cosmetic Act (the 
    act) as amended by the Medical Device Amendments of 1976, the Safe 
    Medical Devices Act of 1990, and the Food and Drug Modernization Act of 
    1997. The agency is classifying sulfide detection devices into class II 
    (special controls) in order to provide a reasonable assurance of safety 
    and effectiveness of the device.
    
    EFFECTIVE DATE: December 7, 1998.
    
    FOR FURTHER INFORMATION CONTACT: Robert S. Betz, Center for Devices and 
    Radiological Health (HFZ-480), Food and Drug Administration, 9200 
    Corporate Blvd., Rockville, MD 20850, 301-827-5283.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        In accordance with section 513(f)(1) of the act (21 U.S.C. 
    360c(f)(1)), devices that were not in commercial distribution before 
    May 28, 1976, the date of the enactment of the Medical Device 
    Amendments 1976, generally referred to as postamendments devices are 
    classified automatically by statute into class III without any 
    rulemaking process. These devices remain in class III and require 
    premarket approval, unless and until the device is classified or 
    reclassified into class I or II or FDA issues an order finding the 
    device to be substantially equivalent, in accordance with section 
    513(i) of the act, to a predicate device that does not require 
    premarket approval. The agency determines whether new devices are 
    substantially equivalent to previously marketed devices by means of 
    premarket notification procedures in section 510(k) of the act (21 
    U.S.C. 360(k)) and 21 CFR part 807 of the FDA regulations.
        Section 513(f)(2) of the act provides that any person who submits a 
    premarket notification under section 510(k) of the act for a device 
    that has not previously been classified may, within 30 days after 
    receiving an order classifying the device in class III under section 
    513(f)(1) of the act, request FDA to classify the device under the 
    criteria set forth in section 513(a)(1). FDA shall, within 60 days of 
    receiving such as request, classify the device by written order. This 
    classification shall be the initial classification of the device. 
    Within 30 days after the issuance of an order classifying the device, 
    FDA must publish a notice in the Federal Register announcing such 
    classification.
        In accordance with section 513(f)(1) of the act, FDA issued an 
    order on May 15, 1998, classifying sulfide detection devices in class 
    III. On May 18, 1998, Diamond General Development Corp. submitted a 
    petition requesting classification into class II of the Diamond 
    Probe/Perio 2000 System that is intended to measure 
    periodontal pocket probing depths, evaluate the presence or absence of 
    bleeding on probing, and to detect the presence of sulfides in 
    periodontal pockets of adult patients. After reviewing the information 
    submitted in the petition, its amendments, K980749, and medical 
    literature, FDA concludes that this device, and substantially 
    equivalent devices of this generic type, can be classified into class 
    II with the establishment of special controls. In accordance with 
    513(f)(2) of the act, FDA reviewed the petition in order to classify 
    the device under the criteria for classification set forth in 513(a)(1) 
    of the act. Devices are to be classified into class II if general 
    controls, by themselves, are insufficient to provide reasonable 
    assurance of the safety and effectiveness of the device and there is 
    sufficient information to develop special controls to provide such 
    assurance. After reviewing the information submitted in the petition, 
    FDA determined that sulfide detection devices can be classified into 
    class II with the establishment of special controls. FDA believes that 
    general controls and special controls will provide reasonable assurance 
    of safety and effectiveness of the device.
        FDA has identified the following risks to health associated with 
    this type of device: (1) Risks associated with the inability to develop 
    adequate directions for use; (2) risks associated with 
    biocompatibility, electrical safety, and sterility; (3) risks related 
    to inaccurate device performance; and (4) risks associated with 
    improper device use.
        FDA determined that the special controls described below address 
    these risks and provide reasonable assurance of the safety and 
    effectiveness of the device. Therefore on July 17, 1998, FDA issued an 
    order to the petitioner classifying the sulfide detection device as 
    described previously into class II subject to the special controls 
    described below.
        Additionally, FDA is codifying the classification of this device by 
    adding Sec. 872.1870 Sulfide detection device.
        In addition to the general controls of the act, the sulfide 
    detection device is subject to the following special controls which, 
    combined with general controls, provide reasonable assurance of the 
    safety and effectiveness of the device: (1) Restriction of the sale, 
    distribution, and use of this device to prescription use in accordance 
    with 21 CFR 801.109; (2) conformance with recognized standards for 
    biocompatibility, electrical safety, and sterility; (3) clinical and 
    analytical testing sufficient to demonstrate that the device accurately 
    measures probing depths, detects the presence or absence of bleeding on 
    probing, and accurately detects the presence of sulfides in periodontal 
    pockets in adult patients; (4) labeling that includes proper 
    instructions for device storage, use, and maintenance.
        Section 510(m) of the act provides that FDA may exempt a class II 
    device from the premarket notification requirements under section 
    510(k) of the act, if FDA determines that premarket notification is not 
    necessary to provide reasonable assurance of the safety and efficacy of 
    the device. FDA has determined premarket notification is necessary to 
    provide reasonable assurance of the safety and effectiveness of the 
    device, and therefore, the device is not exempt from the premarket 
    notification requirements. Thus persons who intend to market this 
    device must submit to FDA a premarket notification prior to marketing 
    the device.
    
    II. Environmental Impact
    
        The agency has determined under 21 CFR 25.34(b) that this action is 
    of a type that does not individually or cumulatively have a significant 
    effect on the human environment. Therefore, neither an environmental 
    assessment nor an environmental impact statement is required.
    
    III. Analysis of Impacts
    
        FDA has examined the impacts of this final rule under Executive 
    Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
    amended by subtitle D of the Small Business Regulatory Flexibility Act 
    (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. 
    L. 104-4). Executive Order 12866 directs agencies to assess all costs 
    of available regulatory alternatives and, when regulation is necessary, 
    to select regulatory approaches that maximize net benefits (including 
    potential economic, environmental, public health
    
    [[Page 59717]]
    
    and safety, and other advantages; distributive impacts; and equity). 
    The agency believes that this final rule is consistent with the 
    regulatory philosophy and principles identified in the Executive Order. 
    In addition, the final rule is not a significant regulatory action as 
    defined by the Executive Order, and so it is not subject to review 
    under the Executive Order.
        The Regulatory Flexibility Act requires agencies to analyze 
    regulatory options that would minimize any significant impact of a rule 
    on small entities. Classification of these devices in class II will 
    relieve manufacturers of the device of the cost of complying with the 
    premarket approval requirements of section 515 of the act (21 U.S.C. 
    360e), and may permit small potential competitors to enter the 
    marketplace by lowering their costs. The agency therefore, certifies 
    that the final rule will not have a significant impact on a substantial 
    number of small entities. In addition, this final rule will not impose 
    costs of $100 million or more on either the private sector or State, 
    local, and tribal governments in the aggregate, and, therefore a 
    summary statement of analysis under section 202(a) of the Unfunded 
    Mandates Act is not required.
    
    IV. Paperwork Reduction Act of 1995
    
        This final 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.
    
    V. References
    
        The following references have been placed on display in the Dockets 
    Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
    Lane, rm. 1061, Rockville, MD, 20852, and may be seen by interested 
    persons between 9 a.m. and 4 p.m., Monday through Friday.
        1. Petition from Diamond General Development Corp., dated May 
    18, 1998.
        2. Solis-Gaffar, M. C., T. Fischer, and A. Gaffar, 
    ``Instrumental Evaluation of Odor Produced by Specific Oral 
    Microorganisms,'' Journal of Cosmetic Chemistry, vol. 30, pp. 241 to 
    247, 1979.
        3. Solis-Gaffar, M. C., K. N. Rustogi, and A. Gaffar, ``Hydrogen 
    Sulfide Production from Gingival Crevicular Fluid,'' Journal of 
    Periodontology, vol. 5 (10), pp. 603 to 606, 1980.
    
    List of Subjects in 21 CFR Part 872
    
        Medical devices.
        Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
    authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
    872 is amended as follows:
    
    PART 872--DENTAL DEVICES
    
        1. The authority citation for 21 CFR part 872 continues to read as 
    follows:
    
        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    
        2. Section 872.1870 is added to subpart B to read as follows:
    
    
    Sec. 872.1870  Sulfide detection device.
    
        (a) Identification. A sulfide detection device is a device 
    consisting of an AC-powered control unit, probe handle, probe tips, 
    cables, and accessories. This device is intended to be used in vivo, to 
    manually measure periodontal pocket probing depths, detect the presence 
    or absence of bleeding on probing, and detect the presence of sulfides 
    in periodontal pockets, as an adjunct in the diagnosis of periodontal 
    diseases in adult patients.
        (b) Classification. Class II (special controls) prescription use in 
    accordance with Sec. 801.109 of this chapter; conformance with 
    recognized standards of biocompatibility, electrical safety, and 
    sterility; clinical and analytical performance testing, and proper 
    labeling.
    
        Dated: August 25, 1998.
     D.B. Burlington,
     Director, Center for Devices and Radiological Health.
    [FR Doc. 98-29569 Filed 11-4-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
12/7/1998
Published:
11/05/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-29569
Dates:
December 7, 1998.
Pages:
59715-59717 (3 pages)
Docket Numbers:
Docket No. 98P-0731
PDF File:
98-29569.pdf
CFR: (1)
21 CFR 872.1870