[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Rules and Regulations]
[Pages 38896-38900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18458]
[[Page 38895]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 862 et al.
Medical Devices: Class I and Class II Generic Devices; Premarket
Notification Exemptions; Final Rule and Proposed Rules
Federal Register / Vol. 60, No. 145 / Friday, July 28, 1995 / Rules
and Regulations
[[Page 38896]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 862 and 872
[Docket No. 94M-0260]
Medical Devices; Exemption From Premarket Notification for
Certain Classified Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is exempting nine
generic types of class I devices from the requirement of premarket
notification. For the exempted devices, FDA has determined that
manufacturers' submissions of premarket notifications are unnecessary
for the protection of the public health and that the agency's review of
such submissions will not advance its public health mission. The
exemptions allow the agency to make better use of its resources and
thus better serve the public. Elsewhere in this issue of the Federal
Register, FDA is publishing a withdrawal of a proposed rule to grant
exemptions from premarket notification for seven other generic types of
class I devices. Also, the agency is proposing to exempt an additional
12 generic types of class I devices from the requirement of premarket
notification. These actions are being taken under the Medical Device
Amendments of 1976.
DATES: Effective August 28, 1995. Beginning on August 28, 1995, all
device manufacturers who have 510(k) submissions pending FDA review for
devices falling within a generic category which is subject to this
rule, will receive a letter stating that the device is exempt from the
premarket notification requirements of the Federal Food, Drug, and
Cosmetic Act.
FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and
Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 21, 1994 (59 FR 37378), FDA issued
a proposed rule to exempt 164 generic types of class I devices from the
requirement of premarket notification, with limitations. Interested
persons were given until October 19, 1994, to comment on the proposed
rule.
During the comment period, FDA received comments that questioned
the appropriateness of the proposed exemptions for a small number of
the devices. FDA also received comments requesting the agency to exempt
56 additional generic types of devices. Furthermore, during this time,
FDA reconsidered the appropriateness or scope of the proposed
exemptions for several devices included in the proposed rule. In the
Federal Register of December 7, 1994 (59 FR 63005), FDA issued a final
rule exempting from the requirement of premarket notification 148 of
the 164 generic types of class I devices included in the July 21, 1994,
proposed rule. In the preamble to the final rule, the agency stated
that, in a future Federal Register notice, it would address the
requests concerning the 56 additional devices and that it was deferring
action on the following 16 devices in order to review the comments
received and to reevaluate whether certain of the devices should be
exempted from the requirement of premarket notification. (See Table 1).
Table 1
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2270........................... Thin-layer chromatography system
for clinical use.
862.2310........................... Clinical sample concentrator.
862.2320........................... Beta or gamma counter for clinical
use.
862.2485........................... Electrophoresis apparatus for
clinical use.
862.2720........................... Plasma oncometer for clinical use.
862.2800........................... Refractometer for clinical use.
862.2920........................... Plasma viscometer for clinical use.
864.2280........................... Cultured animal and human cells.
866.5570........................... Lactoferrin immunological test
system.
868.5620........................... Breathing mouthpiece.
868.5675........................... Rebreathing device.
868.5700........................... Nonpowered oxygen tent.
872.3740........................... Retentive and splinting pin.
872.3810........................... Root canal post.
872.6100........................... Anesthetic warmer.
886.5850........................... Sunglasses (nonprescription).
------------------------------------------------------------------------
After careful review of the comments and reconsideration of the
appropriateness or scope of the proposed exemptions for these devices,
the agency has concluded that for 9 of the 16 generic types of class I
devices listed in Table 1, manufacturers' submissions of premarket
notifications are unnecessary for the protection of the public health
and that the agency's review of such submissions will not advance its
public health mission. These nine devices are listed in Table 2.
Table 2
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2310........................... Clinical sample concentrator.
862.2320........................... Beta or gamma counter for clinical
use.
862.2485......... Electrophoresis apparatus for
clinical use.
862.2720........................... Plasma oncometer for clinical use.
862.2800........................... Refractometer for clinical use.
862.2920........................... Plasma viscometer for clinical use.
872.3740........................... Retentive and splinting pin.
872.3810........................... Root canal post.
872.6100........................... Anesthetic warmer.
------------------------------------------------------------------------
FDA, upon reconsideration, has determined not to grant the proposed
exemptions for the following seven devices. (See Table 3).
Table 3
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2270........................... Thin-layer chromatography system
for clinical use.
864.2280........................... Cultured animal and human cells.
866.5570........................... Lactoferrin immunological test
system.
868.5620........................... Breathing mouthpiece.
868.5675........................... Rebreathing device.
868.5700........................... Nonpowered oxygen tent.
886.5850........................... Sunglasses (nonprescription).
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA is publishing
a withdrawal of the proposed rule to grant exemptions from the
requirement of premarket notification for the seven devices listed
above. FDA's reasons for deciding not to exempt those seven devices are
given in that withdrawal document.
Furthermore, after reviewing the comments requesting FDA to exempt
from the requirement of premarket notification 56 additional generic
types of devices, FDA has concluded that 33 of these 56 devices should
not be exempted from the requirement. As stated below in this document,
10 of these 56 devices, along with 2 additional class I devices, are
being proposed for premarket notification exemption elsewhere in this
issue of the Federal Register. Thirteen of the 56 devices already are
exempted from the requirement of premarket notification.
II. Comments
FDA received 10 comments from trade associations, manufacturer
associations, a dental firm, a consumer products manufacturer, a
company, and a law firm. A summary of the comments and the agency's
response to them is provided below.
[[Page 38897]]
A. Comments Addressing Specific Devices
1. One comment opposed the proposed exemptions from the requirement
of premarket notification for the retentive and splinting pin
(Sec. 872.3740) and the root canal post (Sec. 872.3810). According to
this comment, premarket notification submissions are necessary to
ensure that the material used in these devices are biocompatable in
order to prevent toxicity and/or allergic reactions. The comment also
stated that, because teeth are delicate, these devices must be designed
so that no undue stress will be imparted upon the teeth. According to
this comment, exempting these devices from premarket notification would
result in substandard products being made available to dental
professionals. Another comment in favor of the exemption disagreed,
stating that it is the ``method of use and application'' of these
devices, not the design or materials used in them that is the
determining factor in the safe and effective use of these devices.
Moreover, according to this comment, data relating to these devices
demonstrate that these devices are well-known, established, safe, and
effective.
FDA has concluded that exempting these devices from the requirement
of premarket notification will not result in the marketing of
substandard devices. First, both devices have a long history of safe
use. Second, neither device has a history of adverse events. Third,
literature indicates little potential for any danger to public health.
Finally, the device identifications clearly describe the material
composition of these devices. If devices are made of materials other
than those described in the identification, they will be classified
into another generic type of device or remain in the same generic type
of device, but not be exempt from the requirements of premarket
notification.
2. A comment requested that the proposed exemption for
carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid
calcium-sodium double salt denture adhesive (Sec. 872.3490) be expanded
to include other double salts of polyvinylmethylether maleic acid,
specifically salts involving those ions that achieve the same technical
effect as calcium and sodium, i.e., iron, magnesium, zinc, and
potassium.
FDA disagrees with this comment. Although the comment refers to
carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid
calcium-sodium double salt denture adhesive (Sec. 872.3490), a class I
device, the comment is actually requesting FDA to exempt another
classified dental adhesive device, polyvinylmethylether maleic
anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium
(NACMC) denture adhesive (Sec. 872.3500) which is a class III device.
3. FDA received a comment requesting that an endolumina illuminated
bougie (EIB) device, a silicone elastomer coated fiberoptic bundle
designed to aid in the identification of the esophagus, rectum,
rectosigmoid, and other organs during surgical procedures, be added to
the list of class II, tier 1 devices to be proposed for exemption from
the requirement of premarket notification in a future issue of the
Federal Register.
FDA disagrees with this comment. As stated in the July 21, 1994,
proposal, in early 1994, FDA's Office of Device Evaluation undertook a
risk assessment of all devices in order to ensure the proper allocation
of resources for the review process. Under this risk assessment, all
class I, class II, and class III devices were placed into one of three
tiers based upon the inherent risk associated with each device. Tier 3
devices include all first and second of a kind devices utilizing new
technology or having new intended uses(s), as well as other devices
determined by their inherent risk to require an intensive review. These
tier 3 devices require intensive scientific and labeling review by a
review team as well as advisory panel input. Tier 2 devices include
devices which require routine scientific and labeling review. This tier
encompasses the majority of 510(k)'s and select premarket approval
applications. Tier 1 devices include, among other things, devices which
have a minimal inherent risk and whose review focuses upon intended
use.
FDA had found EIB to be substantially equivalent to both the
gastroenterology-urology fiberoptic retractor (Sec. 876.4530), a class
I device and the class I transilluminator (Sec. 886.1945). However,
upon further consideration, FDA now believes that EIB would have been
more appropriately classified under the fiberoptic light ureteral
catheter (Sec. 876.4020), a class II device, which is also a fiberoptic
bundle that emits light, but is inserted into the ureter to enable it
to be seen during lower abdominal or pelvic surgery. While the specific
indication statement for these two devices are different, their
intended uses are the same and, therefore, the devices are
substantially equivalent. Like the fiberoptic light ureteral catheter,
EIB is used with a high intensity light source, which could produce
heating and potential damage of body tissues. Concerns identified at
the time of classification of the fiberoptic light ureteral catheter
included thermal burns related to the amount of energy transmitted. For
this reason, FDA has placed the fiberoptic light ureteral catheter in
class II, tier 2. Additionally, endoscopes (which could have been
another predicate) and esophageal dilators (which include the
esophageal bougie) are also tier 2 devices. Furthermore, retaining the
EIB device in class II, tier 2 is justified because EIB is a one-of-a-
kind device. FDA has not yet had sufficient experience with this device
to justify a tier 1 premarket review, i.e., a focused labeling review
for intended use/indications for use. For the reasons stated above, the
EIB device will remain a class II, tier 2 device.
B. Comments Requesting FDA to Expand the Exemption from the Requirement
of Premarket Notification to Include an Additional 56 Devices
4. A total of eight comments requested that the 56 devices listed
in Table 4 also be exempted from the requirement of premarket
notification.
Table 4
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2230........................... Chromatographic separation material
for clinical use.
862.2250........................... Gas liquid chromatography system
for clinical use.
866.2600........................... Wood's fluorescent lamp.
868.1930........................... Stethoscope head.
872.3310........................... Coating material for resin
fillings.
872.3730........................... Pantograph.
872.3820........................... Root canal filling resin.
872.4200........................... Dental handpiece and accessories.
872.5470........................... Orthodontic plastic bracket.
872.5500........................... Extraoral orthodontic headgear.
872.6050........................... Saliva absorber.
872.6390........................... Dental floss (including devices
made of any inert materials).
872.6770........................... Cartridge syringe.
874.1060........................... Acoustic chamber for audiometric
testing.
874.4140........................... Ear, nose, and throat bur.
874.4175........................... Nasopharyngeal catheter.
874.4770........................... Otoscope.
874.5220........................... Ear, nose, and throat drug
administration device.
874.5800........................... External nasal splint.
876.4890........................... Urological table and accessories
(manually powered).
876.5160........................... Urological clamp for males.
876.5250........................... Urine collector and accessories
(not connected to indwelling
catheter).
878.4040........................... Surgical apparel (except surgical
gowns and masks).
878.4460........................... Surgeon's gloves.
880.5110........................... Hydraulic adjustable hospital bed.
[[Page 38898]]
880.5120........................... Manual adjustable hospital bed.
880.5180........................... Burn sheet.
880.6250........................... Patient examination glove.
880.6280........................... Medical insole.
880.6350........................... Battery-powered medical examination
light.
880.6970........................... Liquid crystal vein locator.
884.5150........................... Nonpowered breast pump.
884.5425........................... Scented or scented deodorized
menstrual pad.
884.5435........................... Unscented menstrual pad.
886.4370........................... Keratome (AC powered).
888.5960........................... Cast removal instrument (AC
powered).
892.1300........................... Nuclear rectilinear scanner.
892.1320........................... Nuclear uptake probe.
892.1330........................... Nuclear whole body scanner.
892.1410........................... Nuclear electrocardiograph
synchronizer.
892.1610........................... Diagnostic x-ray beam limiting
device.
892.1620........................... Cine or spot flourographic x-ray
camera.
892.1760........................... Diagnostic x-ray tube housing
assembly.
892.1770........................... Diagnostic x-ray tube mount.
892.1830........................... Radiographic patient cradle.
892.1850........................... Radiographic film cassette.
892.1860........................... Radiographic film/cassette changer.
892.1880........................... Wall-mounted radiographic cassette
holder.
892.1890........................... Radiographic film illuminator.
892.1910........................... Radiographic grid.
892.1970........................... Radiographic ECG/respirator
synchronizer.
892.1980........................... Radiologic table.
892.5770........................... Powered radiation therapy patient
support assembly.
892.5780........................... Light beam patient position
indicator.
892.5930........................... Therapeutic x-ray tube housing
assembly.
892.6500........................... Personnel protective shield.
------------------------------------------------------------------------
FDA has concluded that 18 of the 56 devices listed in Table 4 are
not candidates for exemption from the requirement of premarket
notification because they are currently classified into class II and/or
class III. These devices are listed in Table 5.
Table 5
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
872.3310........................... Coating material for resin
fillings.
872.3820........................... Root canal filling resin.
872.5470........................... Orthodontic plastic bracket.
872.5500........................... Extraoral orthodontic headgear.
872.6770........................... Cartridge syringe.
884.5425........................... Scented or scented deodorized
menstrual pad.
892.1610........................... Diagnostic x-ray beam limiting
device.
892.1620........................... Cine or spot flourographic x-ray
camera.
892.1760........................... Diagnostic x-ray tube housing
assembly.
892.1770........................... Diagnostic x-ray tube mount.
892.1830........................... Radiographic patient cradle.
892.1850........................... Radiographic film cassette.
892.1860........................... Radiographic film/cassette changer.
892.1880........................... Wall-mounted radiographic cassette
holder.
892.1980........................... Radiologic table.
892.5770........................... Powered radiation therapy patient
support assembly.
892.5780........................... Light beam patient position
indicator.
892.5930........................... Therapeutic x-ray housing assembly.
------------------------------------------------------------------------
In accordance with section 513(e)(1) of the act (21 U.S.C.
360c(e)(1)), any interested person may petition FDA to reclassify a
device based on new information respecting such a device and to exempt
such a device from the requirement of premarket notification. The form
and content required for such a petition are set forth in 21 CFR
860.123. The request and reasons supporting the request for exemption
from the requirement of premarket notification should be included in
the supplemental data sheet. If a device is reclassified into class I,
FDA may also exempt the device from the requirement of premarket
notification.
Thirteen of the 56 devices listed in Table 4 have already been
exempted from premarket notification procedures on the dates listed
below. These devices are listed in Table 6.
Table 6
------------------------------------------------------------------------
Federal Register
Date citation 21 CFR Device
------------------------------------------------------------------------
Nov. 9, 1982..... 47 FR 50823...... 866.2600........ Wood's
fluorescent
lamp.
June 12, 1989.... 54 FR 25042...... 868.1930........ Stethoscope
head.
Aug. 12, 1987.... 52 FR 30082...... 872.3730........ Pantograph.
Apr. 5, 1989..... 54 FR 13828...... 872.6050........ Saliva absorber.
Dec. 7, 1994..... 59 FR 63005...... 874.5220........ Ear, nose, and
throat drug
administration
device.
Aug. 25, 1987.... 52 FR 32110...... 874.5800........ External nasal
splint.
June 12, 1989.... 54 FR 25042...... 876.4890........ Urological table
and accessories
(manually
powered).
June 12, 1989.... 54 FR 25042...... 880.5110........ Hydraulic
adjustable
hospital bed.
June 12, 1989.... 54 FR 25042...... 880.5120........ Manual
adjustable
hospital bed.
Dec. 7, 1994..... 59 FR 63005...... 880.5180........ Burn sheet.
June 12, 1989.... 54 FR 25042...... 880.6280........ Medical insole.
Oct. 21, 1980.... 45 FR 69682...... 880.6350........ Battery-powered
medical
examination
light.
June 12, 1989.... 54 FR 25042...... 880.6970........ Liquid crystal
vein locator.
------------------------------------------------------------------------
Ten of the 56 devices listed in Table 4 are candidates for
exemption from the requirement of premarket notification. These
devices, which are listed in Table 7, along with the flotation cushion
(Sec. 890.3175) and the traction accessory (Sec. 890.5925), are being
proposed for premarket notification exemption elsewhere in today's
issue of the Federal Register.
Table 7
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2230........................... Chromatographic separation material
for clinical use.
872.2230........................... Dental floss (including devices
made of inert materials).
874.1060........................... Acoustic chamber for audiometric
testing.
874.4140........................... Ear, nose, and throat bur.
874.4175........................... Nasopharyngeal catheter.
[[Page 38899]]
874.4770........................... Otoscope.
884.5150........................... Nonpowered breast pump.
884.5435........................... Unscented menstrual pad.
888.5960........................... Cast removal instrument (AC
powered).
892.6500........................... Personnel protective shield.
------------------------------------------------------------------------
For fifteen of the 56 devices listed in Table 8, FDA has concluded
that these devices are not candidates for exemption from premarket
notification procedures because they do not meet the criteria for
exemption which is set out below.
Table 8
------------------------------------------------------------------------
21 CFR Device
------------------------------------------------------------------------
862.2250........................... Gas liquid chromatography system
for clinical use.
872.4200........................... Dental handpiece and accessories.
876.5160........................... Urological clamp for males.
876.5250........................... Urine collector and accessories
(not connected to indwelling
catheter).
878.4040........................... Surgical apparel (except surgical
gowns and masks).
878.4460........................... Surgeon's gloves.
880.6250........................... Patient examination glove.
886.4370........................... Keratome (AC powered).
892.1300........................... Nuclear rectilinear scanner.
892.1320........................... Nuclear uptake probe.
892.1330........................... Nuclear whole body scanner.
892.1410........................... Nuclear electrocardiograph
synchronizer.
892.1890........................... Radiographic film illuminator.
892.1910........................... Radiographic grid.
892.1970........................... Radiographic ECG/respirator
synchronizer.
------------------------------------------------------------------------
As stated in the preamble of July 21, 1994, proposal, in order for
devices to be exempted from the requirement of premarket notification,
they must meet all of the following criteria: (1) The device does not
have a significant history of false or misleading claims; (2) the
device does not have a significant history of risk; (3) characteristics
of the device necessary for its safe and effective performance are well
established; (4) anticipated changes in the device that could affect
safety and effectiveness will either: (a) be readily detectable by
users by visual examination or other means or (b) not materially
increase the risk of injury, incorrect diagnosis, or ineffective
treatment; and (5) any changes in the device would not be likely to
result in a change in the device's classification.
The gas liquid chromatography system for clinical use
(Sec. 862.2250); the urological clamp for males (Sec. 876.5160); and
the urine collector and accessories (Sec. 876.5250) are class I, tier 2
devices. As stated above, tier 2 devices require review of performance
data because characteristics of these devices necessary for their safe
and effective performance are not well established.
Characteristics of the dental handpiece and accessories
(Sec. 872.4200) and the nuclear rectilinear scanner (Sec. 892.1300),
which are necessary for their safety and effective performance, are not
well established. Moreover, anticipated changes in the devices that
could affect safety and effectiveness are not readily detectable
visually or by routine testing and could materially increase the risk
of injury, incorrect diagnosis, or ineffective treatment.
The keratome (Sec. 886.4370) is not a candidate for exemption from
premarket notification because anticipated changes that could affect
the safety and effectiveness of the device are not readily detectable
visually or by routine testing.
Surgical apparel (except surgical gowns and masks (Sec. 878.4040))
and surgeons's gloves (Sec. 878.4460) are not candidates for exemption
from premarket notification procedures because anticipated changes that
could affect safety and effectiveness are not readily detectable
visually or by routine testing and could materially increase the risk
of injury, namely the transmission of blood bourne pathogens.
In the Federal Register of January 13, 1989 (53 FR 1604), the
exemptions from premarket notification and current good manufacturing
practices for patient examination gloves (Sec. 880.6250) were revoked
because of the importance of this device in preventing the transmission
between patients and health care workers of human immunodeficiency
virus (HIV) that causes acquired immune deficiency syndrome (AIDS).
The nuclear uptake probe (Sec. 892.1320); the nuclear
electrocardiograph synchronizer (Sec. 892.1410); the nuclear whole body
scanner (Sec. 892.1330); the radiographic film illuminator
(Sec. 892.1890); the radiographic grid (Sec. 892.1910); and the
radiographic ECG/respirator synchronizer (Sec. 892.1970) are not
candidates for exemption from the requirement of premarket notification
because anticipated changes that could affect the devices' safety and
effectiveness are not readily detectable visually or by routine testing
and could materially increase the risk of injury, incorrect diagnosis,
or ineffective treatment.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) 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.
IV. Analysis of Impact
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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 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 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. Because this final rule reduces a regulatory burden
by exempting manufacturers of devices subject to the final rule from
the requirement of premarket notification, the agency certifies that
the final rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
List of Subjects in 21 CFR Parts 862 and 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 parts
862 and 872 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: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 862.2310 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2310 Clinical sample concentrator.
* * * * *
[[Page 38900]]
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
3. Section 862.2320 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2320 Beta or gamma counter for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
4. Section 862.2485 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2485 Electrophoresis apparatus for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
5. Section 862.2720 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2720 Plasma oncometer for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
6. Section 862.2800 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2800 Refractometer for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
7. Section 862.2920 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2920 Plasma viscometer for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 872--DENTAL DEVICES
8. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
9. Section 872.3740 is amended by revising paragraph (b) to read as
follows:
Sec. 872.3740 Retentive and splinting pin.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
10. Section 872.3810 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3810 Root canal post.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
11. Section 872.6100 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6100 Anesthetic warmer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18458 Filed 7-27-95; 8:45 am]
BILLING CODE 4160-01-F
