[Federal Register Volume 59, Number 139 (Thursday, July 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17705]
[[Page Unknown]]
[Federal Register: July 21, 1994]
_______________________________________________________________________
Part VI
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 862, et al.
Medical Devices; Proposed Exemptions From Premarket Notification for
Certain Classified Devices; Proposed Rules
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882,
886, 888, 890, and 892
[Docket No. 94M-0260]
Medical Devices; Proposed Exemptions From Premarket Notification
for Certain Classified Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to exempt
164 generic types of class I devices from the requirement of premarket
notification, with limitations. 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. Granting the exemptions will allow the agency to make better
use of its resources and thus better serve the public.
DATES: Submit written comments by October 19, 1994. FDA is proposing
that any final rule that may issue based on this proposed rule become
effective 30 days after the date of its publication in the Federal
Register.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4765.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (Pub. L. 94-295, hereinafter
called the amendments) and the Safe Medical Devices Act of 1990 (the
SMDA), establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the act (21 U.S.C. 360c)
establishes three classes of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness: Class I, general controls; class II, special controls;
and class III, premarket approval.
Section 513(d)(2)(A) of the act (21 U.S.C. 360c(d)(2)(A))
authorizes FDA to exempt, by regulation, a generic type of class I
device from, among other things, the requirement of premarket
notification in section 510(k) of the act (21 U.S.C. 360(k)). Such an
exemption permits manufacturers to introduce into commercial
distribution generic types of devices without first submitting a
premarket notification to FDA. When FDA issued proposed regulations
classifying preamendments devices, the agency focused on granting
exemptions from the requirement of premarket notification principally
when the advisory panels included them in their recommendations to the
agency. Subsequently, FDA decided to exempt certain additional class I
devices from the requirement of premarket notification in order to
reduce the number of unnecessary premarket notifications. This action
helped to free agency resources for the review of more complex
notifications to FDA.
Previously, FDA exempted 293 generic types of class I devices from
the requirement of premarket notification, with limitations. Some of
these devices were exempted from the requirement of premarket
notification when the devices were initially classified into class I.
However, the majority of these devices were exempted from the
requirement of premarket notification after being classified into class
I. These subsequent exemptions from the requirement of premarket
notification appear in the following Federal Register publications (see
Table 1).
Table 1
----------------------------------------------------------------------------------------------------------------
Date Federal Register citation Type of device No. of devices
----------------------------------------------------------------------------------------------------------------
Aug. 25, 1987............. 52 FR 32110............... Ear, Nose and Throat........... 4
June 8, 1988.............. 53 FR 21447............... Clinical Chemistry and 21
Toxicology.
Sept. 14, 1988............ 53 FR 35602............... Ophthalmic..................... 55
Dec. 29, 1988............. 53 FR 52952............... Orthopedic..................... 7
Apr. 5, 1989.............. 54 FR 13826............... General and Plastic Surgery.... 8
Apr. 5, 1989.............. 54 FR 13828............... Dental......................... 22
Apr. 5, 1989.............. 54 FR 13831............... Radiology...................... 4
June 12, 1989............. 54 FR 25042............... Hematology and Pathology....... 24
Immunology and Microbiology.... 37
Anesthesiology................. 13
Cardiovascular................. 3
Gastroenterology and Urology... 9
General Hospital and Personal 6
Use.
Neurological................... 7
Obstetrical and Gynecological.. 3
Physical Medicine.............. 2
----------------------------------------------------------------------------------------------------------------
II. Description of Proposed Exemptions
In considering whether to exempt additional class I devices from
premarket notification, FDA focused on whether notification for the
type of device is unnecessary for the protection of the public health.
For the devices proposed in this document to be exempted from premarket
notification, FDA has concluded that notification is unnecessary
primarily for the following reasons:
(1) The device does not have a significant history of false or
misleading claims or of risks associated with inherent characteristics
of the device, such as device design or materials. When making these
determinations, FDA generally has considered the frequency,
persistence, cause, or seriousness of such claims or risks, as well as
other factors deemed relevant.
(2) In general, the following factors apply: (a) Characteristics of
the device necessary for its safe and effective performance are well
established; (b) anticipated changes in the device that could affect
safety and effectiveness will either: (i) Be readily detectable by
users by visual examination or other means, such as routine testing,
before causing harm, e.g., testing of a clinical laboratory reagent
with positive and negative controls; or (ii) not materially increase
the risk of injury, incorrect diagnosis, or ineffective treatment; and
(c) any changes in the device would not be likely to result in a change
in the device's classification.
FDA has made the determinations described above based on its
knowledge of the device, including past experience and relevant reports
or studies on device performance. If FDA has concerns only about
certain types of changes to a particular class I device, the agency may
grant a limited exemption from premarket notification for that generic
type of device. A limited exemption will specify the types of changes
to the device for which manufacturers are required to submit a
premarket notification. For example, FDA may exempt a device from the
requirement of premarket notification except when a manufacturer
intends to use a different material.
FDA advises manufacturers that an exemption from the requirement of
premarket notification is not an exemption from any of the other
general controls, including current good manufacturing practices
(CGMP's), unless explicitly stated. Indeed, FDA's decision to propose
510(k) exemptions for these devices is based, in part, on the fact that
compliance with CGMP's will help insure product quality.
FDA's decision to grant an exemption from the requirement of
premarket notification for a generic type of class I device will be
based upon the existing and reasonably foreseeable characteristics of
commercially distributed devices within that generic type. Because FDA
cannot anticipate every change or modification of a class I device
exempt from premarket notification requirements that could
significantly affect the safety or effectiveness, manufacturers of any
commercially distributed class I device for which FDA has granted an
exemption from the requirement of premarket notification are still
required to submit a premarket notification to FDA before introducing a
device or delivering it for introduction into interstate commerce for
commercial distribution when:
(1) The 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 the preamendments device to which it has been
determined to be substantially equivalent; 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) The modified device operates using a different fundamental
scientific technology than used by the device before May 28, 1976;
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 a deoxyribonucleic acid (DNA)
probe or nucleic acid hybridization technology rather than culture or
immunoassay technology.
Such changes or modifications to class I devices that are exempt
from premarket notification would mean the exemption would no longer
apply. Changes or modifications to devices that are not exempt from
premarket notification requirements under any regulation must undergo a
more comprehensive assessment to determine the impact of the change or
modification on the device's safety and effectiveness. FDA intends to
develop guidance clarifying when a change or modification to a device
requires submission of a premarket notification as defined in 21 CFR
807.81(a)(3).
On the dates listed, FDA published final regulations classifying,
among others, the devices listed below. When FDA classified these
devices, the agency did not propose exempting them from the requirement
of premarket notification. Based on the analysis described above, FDA
has now determined that premarket notification with respect to the
devices listed below is unnecessary for the protection of the public
health and will not advance FDA's public health mission. This approach
is consistent with the recommendation in the May 1993 report of the
Subcommittee on Oversight and Investigations of the Committee on Energy
and Commerce, U.S. House of Representatives, entitled ``Less Than the
Sum of its Parts Reforms Needed in the Organization, Management, and
Resources of The Food and Drug Administration's Center for Devices and
Radiological Health.''
Earlier this year, the Office of Device Evaluation undertook a risk
assessment of all devices in order to ensure the proper allocation of
resources in the review process. All of the class I devices listed
below were placed in Tier I, the category of devices which have a
minimal inherent risk and whose review focuses upon intended use. A
number of class II devices were also included in the Tier I evaluation
process. FDA intends to consider proposing exemptions from the
requirement of premarket notification for these devices. In the near
future, FDA believes that exempting these devices from premarket
notification will allow the agency to better use its available
resources to protect the public health.
FDA is proposing to exempt from the requirement of premarket
notification, with limitations, the 164 generic type of class I devices
listed in Table 2 below:
Table 2
----------------------------------------------------------------------------------------------------------------
No. of devices
CFR part Title proposed to be
exempt
----------------------------------------------------------------------------------------------------------------
862................. Clinical Chemistry and Clinical Toxicology Devices; May 1, 1987 (52 FR 7
16102).
864................. Hematology and Pathology Devices; September 12, 1980 (45 FR 60576)..... 6
866................. Immunology and Microbiology Devices; November 9, 1982 (47 FR 50814).... 8
868................. Anesthesiology Devices; July 16, 1982 (47 FR 33130).................... 5
870................. Cardiovascular Devices; February 5, 1980 (45 FR 7904).................. 1
872................. Dental Devices; August 12, 1987 (52 FR 30082); November 20, 1990 (55 FR 38
48436).
874................. Ear, Nose and Throat Devices; November 6, 1986 (51 FR 40378)........... 4
876................. Gastroenterology-Urology Devices; November 23, 1983 (48 FR 53012)...... 1
878................. General and Plastic Surgery Devices; June 24, 1988 (53 FR 23856)....... 16
880................. General Hospital and Personal Use Devices; October 21, 1980 (45 FR 13
69678).
882................. Neurological Devices; September 4, 1979 (44 FR 51726).................. 14
886................. Ophthalmic Devices; September 2, 1987 (52 FR 33346).................... 36
888................. Orthopedic Devices; September 4, 1987 (52 FR 33686).................... 5
890................. Physical Medicine Devices; November 23, 1983 (48 FR 53032)............. 6
892................. Radiology Devices; January 20, 1988 (53 FR 1554)....................... 4
------------------
Total......... ....................................................................... 164
----------------------------------------------------------------------------------------------------------------
Table 3.--Clinical Chemistry and Clinical Toxicology Devices
------------------------------------------------------------------------
Section 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.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 3 above.
However, the proposed exemptions for the clinical sample concentrator
(Sec. 862.2310), the beta or gamma counter for clinical use
(Sec. 862.2320), the electrophoresis apparatus for clinical use
(Sec. 862.2485), the plasma oncometer for clinical use (Sec. 862.2720),
the refractometer for clinical use (Sec. 862.2800), and the plasma
viscometer for clinical use (Sec. 862.2920) are limited and would apply
only to those products intended for general use, which make no specific
claims, and which include submissions containing a certified statement
that the requirements for labeling of in vitro diagnostic products
contained in 21 CFR 809.10 will be followed.
Table 4.--Hematology and Pathology Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
864.2280.......................... Cultured animal and human cells.
864.5350.......................... Microsedimentation centrifuge.
864.7660.......................... Leukocyte alkaline phosphate test.
864.7675.......................... Leukocyte peroxidase test.
864.7900.......................... Thromboplastin generation test.
864.8500.......................... Lymphocyte separation medium.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 4 above.
Table 5.--Immunology and Microbiology Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
866.5170.......................... Breast milk immunological test
system.
866.5220.......................... Cohn fraction II immunological test
system.
866.5230.......................... Colostrum immunological test system.
866.5360.......................... Cohn fraction IV immunological test
system.
866.5370.......................... Cohn fraction V immunological test
system.
866.5540.......................... Immunoglobulin G (Fd fragment
specific) immunological test
system.
866.5570.......................... Lactoferrin immunological test
system.
866.5700.......................... Whole human plasma of serum
immunological test system.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 5 above.
Table 6.--Anesthesiology Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
868.5340.......................... Nasal oxygen cannula.
868.5350.......................... Nasal oxygen catheter.
868.5620.......................... Breathing mouthpiece.
868.5675.......................... Rebreathing device.
868.5700.......................... Nonpowered oxygen tent.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 6 above.
Table 7.--Cardiovascular Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
870.1875.......................... Stethoscope.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for the device in Table 7 above. However, this
proposed exemption is limited and would apply only to the mechanical
stethoscope, the manual stethoscope, and the direct (acoustic)
stethoscope.
Table 8.--Dental Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
872.1500.......................... Gingival fluid measurer.
872.1820.......................... Dental X-Ray exposure alignment
device.
872.3100.......................... Dental amalgamator.
872.3130.......................... Preformed anchor.
872.3165.......................... Precision attachment.
872.3240.......................... Dental burr.
872.3285.......................... Preformed clasp.
872.3330.......................... Preformed crown.
872.3350.......................... Gold or stainless steel cusp.
872.3360.......................... Preformed cusp.
872.3410.......................... Ethylene oxide homopolymer and/or
carboxymethylcellulose sodium
denture adhesive.
872.3450.......................... Ethylene oxide homopolymer and/or
karaya adhesive.
872.3490.......................... Carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid
calcium-sodium double salt denture
adhesive.
872.3520.......................... OTC denture cleanser.
872.3530.......................... Mechanical dental cleaner.
872.3580.......................... Preformed gold denture tooth.
872.3670.......................... Resin impression tray material.
872.3740.......................... Retentive and splinting pin.
872.3810.......................... Root canal post.
872.3900.......................... Posterior artificial tooth with a
metal insert.
872.3910.......................... Backing and facing for an artificial
tooth.
872.4130.......................... Intraoral dental drill.
872.4535.......................... Dental diamond instrument.
872.4620.......................... Fiber optic dental light.
872.4730.......................... Dental injecting needle.
872.5410.......................... Orthodontic appliances and
accessories.
872.5525.......................... Preformed tooth positioner.
872.5550.......................... Solid teething ring (CPSC regulates
if no medical claims).
872.6030.......................... Oral cavity abrasive polishing
agent.
872.6100.......................... Anesthetic warmer.
872.6140.......................... Articulation paper.
872.6250.......................... Dental chair and accessories.
872.6300.......................... Rubber dam and accessories.
872.6475.......................... Heat source for bleaching teeth.
872.6510.......................... Oral irrigation unit.
872.6640.......................... Dental operative unit and
accessories.
872.6865.......................... Powered toothbrush.
872.6890.......................... Intraoral dental wax.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 8 above. The
proposed exemption for the dental chair and accessories (Sec. 872.6250)
is limited and would apply only to products not containing an operative
unit. The proposed exemption for the rubber dam and accessories
(Sec. 872.6300) is also limited and would apply only to the
accessories, i.e., the rubber dam clamp, the rubber dam frame and
forceps for the clamp. Finally, the proposed exemption for the dental
operative unit and accessories (Sec. 872.6640) is limited and would
apply only to the accessories tray to the dental operative unit.
Table 9.--Ear, Nose, and Throat Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
874.3375.......................... Battery-powered artificial larynx.
874.4750.......................... Laryngostroboscope.
874.5220.......................... Ear, nose, and throat drug
administration device.
874.5800.......................... External nasal splint.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 9 above.
Table 10.--Gastroenterology-Urology Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
876.5970.......................... Hernia support.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for the device in Table 10 above.
Table 11.--General and Plastic Surgery Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
878.1800.......................... Speculum and accessories.
878.3750.......................... External prosthesis adhesive.
878.3800.......................... External aesthetic restoration
prosthesis.
878.3900.......................... Inflatable extremity splint.
878.4100.......................... Organ bag.
878.4380.......................... Drape adhesive.
878.4440.......................... Eye pad.
878.4470.......................... Surgeon's gloving cream.
878.4635.......................... Ultraviolet lamp for tanning.
878.4660.......................... Skin marker.
878.4700.......................... Surgical microscope and accessories.
878.4730.......................... Surgical skin degreaser/adhesive
solvent.
878.4800.......................... Manual surgical instrument for
general use.
878.4930.......................... Suture retention device.
878.4950.......................... Manual operating table and
accessories and manual operating
chair and accessories.
878.5900.......................... Non-pneumatic tourniquet.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 11 above.
However, the proposed exemption for the organ bag (Sec. 878.4100) is
limited and would apply only to intestinal organ bags.
Table 12.--General Hospital and Personal Use Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
880.2400.......................... Bed patient monitor.
880.2720.......................... Patient scale.
880.5180.......................... Burn sheet.
880.5210.......................... Intravascular catheter securement
device.
880.5240.......................... Medical adhesive tape and adhesive
bandage.
880.5630.......................... Nipple shield.
880.5740.......................... Suction snakebite kit.
880.5780.......................... Medical support stocking
880.5950.......................... Umbilical occlusion device.
880.6060.......................... Medical disposable bedding.
880.6150.......................... Ultrasonic cleaner for medical
instruments.
880.6190.......................... Mattress cover for medical purposes.
880.6900.......................... Hand-carried stretcher.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 12 above.
Table 13.--Neurological Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
882.1430.......................... Electroencephalograph test signal
generator.
882.1700.......................... Percussor.
882.1925.......................... Ultrasonic scanner calibration test
block.
882.4030.......................... Skull plate anvil.
882.4125.......................... Neurosurgical chair.
882.4190.......................... Clip forming/cutting instrument.
882.4200.......................... Clip removal instrument.
882.4215.......................... Clip rack.
882.4440.......................... Neurosurgical headrest.
882.4500.......................... Cranioplasty material forming
instrument.
882.4525.......................... Microsurgical instrument.
882.4535.......................... Nonpowered neurosurgical instrument.
882.4600.......................... Leukotome.
882.4900.......................... Skullplate screwdriver.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 13 above.
Table 14.--Ophthalmic Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
886.1040.......................... Ocular esthesiometer.
886.1050.......................... Adaptometer (biophotometer).
886.1070.......................... Anomaloscope.
886.1090.......................... Haidlinger brush.
886.1140.......................... Ophthalmic chair.
886.1160.......................... Color vision plate illuminator.
886.1250.......................... Euthyscope.
886.1290.......................... Fixation device.
886.1340.......................... Haploscope.
886.1350.......................... Keratoscope.
886.1425.......................... Lens measuring instrument.
886.1430.......................... Ophthalmic contact lens radius
measuring device.
886.1435.......................... Maxwell spot.
886.1450.......................... Corneal radius measuring device.
886.1660.......................... Gonioscopic prism.
886.1680.......................... Ophthalmic projector.
886.1690.......................... Pupillograph.
886.1700.......................... Pupillometer.
886.1810.......................... Tangent screen (campimeter).
886.1860.......................... Ophthalmic instrument stand.
886.1870.......................... Stereoscope.
886.1910.......................... Spectacle dissociation test system.
886.1945.......................... Transilluminator.
886.4250.......................... Ophthalmic electrolysis unit.
886.4350.......................... Manual ophthalmic surgical
instrument.
886.4360.......................... Ocular surgery irrigation device.
886.4570.......................... Ophthalmic surgical marker.
886.4750.......................... Ophthalmic eye shield.
886.4855.......................... Ophthalmic instrument table.
886.5820.......................... Closed-circuit television reading
system.
886.5840.......................... Magnifying spectacles.
886.5842.......................... Spectacle frame.
886.5844.......................... Prescription spectacle lens.
886.5850.......................... Sunglasses (nonprescription).
886.5900.......................... Electronic vision aid.
886.5915.......................... Optical vision aid.
------------------------------------------------------------------------
FDA is proposing to grant exemption from the requirement of
premarket notification for each of the devices in Table 14 above. The
proposed exemption for the keratoscope (Sec. 886.1350) and for the
corneal radius measuring device (Sec. 886.1450) is limited and does not
include topographers. Additionally, the proposed exemption for the
ophthalmic chair (Sec. 886.1140), keratoscope (Sec. 886.1350),
pupillometer (Sec. 886.1700), tangent screen (Sec. 886.1810),
ophthalmic instrument stand (Sec. 886.1860), stereoscope
(Sec. 886.1870), spectacle dissociation test system (Sec. 886.1910),
ophthalmic instrument table (Sec. 886.4855), and optical vision aid
(Sec. 886.5915) would apply to alternating current (AC)-powered
devices. The proposed exemption for nonprescription sunglasses
(Sec. 886.5850) is limited and applies only to sunglasses which: (1)
Transmit less than 1.0 percent UV-B radiation, (2) transmit less than
5.0 percent UV-A radiation, (3) meet impact resistance (21 CFR
801.410), (4) are made with nonflammable materials, and (5) limit
claims to reduction of the risk of age-related cataracts, and/or
photokeratitis. The proposed exemption for the euthyscope
(Sec. 886.1250), transilluminator (Sec. 886.1945) and ophthalmic
electrolysis unit (Sec. 886.4250) is limited and would apply only to
battery-powered devices (AC-powered devices are class II devices).
Table 15.--Orthopedic Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
888.4200.......................... Cement dispenser.
888.4210.......................... Cement mixer for clinical use.
888.4230.......................... Cement ventilation tube.
888.4540.......................... Orthopedic manual surgical
instrument.
888.5940.......................... Cast components.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 15 above.
Table 16.--Physical Medicine Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
890.1175.......................... Electrode cable.
890.3100.......................... Mechanical chair.
890.3750.......................... Mechanical table.
890.3920.......................... Wheelchair component.
890.3940.......................... Wheelchair platform scale.
890.5765.......................... Pressure-applying device.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 16 above.
Table 17.--Radiology Devices
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
892.1130.......................... Nuclear whole body counter.
892.1350.......................... Nuclear scanning bed.
892.1640.......................... Radiographic film marking system.
892.5740.......................... Radionuclide teletherapy source.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 17 above. The
proposed exemption for the nuclear scanning bed (Sec. 892.1350) is
limited and would apply only if the device is labeled with weight
limit, is used with planar scanning only, and is not for diagnostic X-
ray use.
III. Environmental Impact
The agency has determined under 21 CFR 25.249(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 Impacts
FDA has examined the impacts of the proposed 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 proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
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
proposal on small entities. Because this proposal would reduce a
regulatory burden by exempting manufacturers of devices subject to the
rule from the requirements of premarket notification, the agency
certifies that the proposed 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.
V. Request for Comments
Interested persons may, on or before October 19, 1994, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 888, and 890
Medical devices.
21 CFR Part 864
Blood, 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, it is
proposed that 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878,
880, 882, 886, 888, 890, and 892 be 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 862.2270 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2270 Thin-layer chromatography system for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. Particular components of TLC systems, i.e., the thin-layer
chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC
ultraviolet light, are also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
3. Section 862.2310 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2310 Clinical sample concentrator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
4. Section 862.2320 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2320 Beta and 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 only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
5. 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 only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
6. 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 only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
7. 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 only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
8. 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 only when the products are intended for general use, make no
specific claims, and only if labeling follows the format in Sec. 809.10
of this chapter.
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
9. The authority citation for 21 CFR part 864 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).
10. 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. The devices are exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
11. Section 864.5350 is amended by revising paragraph (b) to read
as follows:
Sec. 864.5350 Microsedimentation centrifuge.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
12. Section 864.7660 is amended by revising paragraph (b) to read
as follows:
Sec. 864.7660 Leukocyte alkaline phosphatase test.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
13. Section 864.7675 is amended by revising paragraph (b) to read
as follows:
Sec. 864.7675 Leukocyte peroxidase test.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
14. Section 864.7900 is amended by revising paragraph (b) to read
as follows:
Sec. 864.7900 Thromboplastin generation test.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
15. Section 864.8500 is amended by revising paragraph (b) to read
as follows:
Sec. 864.8500 Lymphocyte separation medium.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
16. The authority citation for 21 CFR part 866 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).
17. Section 866.5170 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5170 Breast milk immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
18. Section 866.5220 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5220 Cohn fraction II immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
19. Section 866.5230 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5230 Colostrum immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
20. Section 866.5360 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5360 Cohn fraction IV immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
21. Section 866.5370 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5370 Cohn fraction V immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
22. Section 866.5540 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5540 Immunoglobin G (Fd fragment specific) immunological test
system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
23. Section 866.5570 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5570 Lactoferrin immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
24. Section 866.5700 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5700 Whole human plasma of serum immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 868--ANESTHESIOLOGY DEVICES
25. The authority citation for 21 CFR part 868 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).
26. Section 868.5340 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5340 Nasal oxygen cannula.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
27. Section 868.5350 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5350 Nasal oxygen catheter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
28. Section 868.5620 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5620 Breathing mouthpiece.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
29. Section 868.5675 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5675 Rebreathing device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
30. Section 868.5700 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5700 Nonpowered oxygen tent.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 870--CARDIOVASCULAR DEVICES
31. The authority citation for 21 CFR part 870 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).
32. Section 870.1875 is amended by revising paragraph (a)(2) to
read as follows:
Sec. 870.1875 Stethoscope.
(a) * * *
(2) Classification. Class I. The mechanical stethoscope, the manual
stethoscope and the direct (acoustic) stethoscope are exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
* * * * *
PART 872--DENTAL DEVICES
33. 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).
34. Section 872.1500 is amended by revising paragraph (b) to read
as follows:
Sec. 872.1500 Gingival fluid measurer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
35. Section 872.1820 is amended by revising paragraph (b) to read
as follows:
Sec. 872.1820 Dental X-ray exposure alignment device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
36. Section 872.3100 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3100 Dental amalgamator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
37. Section 872.3130 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3130 Preformed anchor.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
38. Section 872.3165 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3165 Precision attachment.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
39. Section 872.3240 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3240 Dental bur.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807.
40. Section 872.3285 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3285 Preformed clasp.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
41. Section 872.3330 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3330 Preformed crown.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
42. Section 872.3350 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3350 Gold or stainless steel cusp.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
43. Section 872.3360 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3360 Preformed cusp.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
44. Section 872.3410 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose
sodium denture adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
45. Section 872.3450 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3450 Ethylene oxide homopolymer and/or karaya adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
46. Section 872.3490 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3490 Carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid calcium-sodium double salt denture
adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
47. Section 872.3520 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3520 OTC denture cleanser.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
48. Section 872.3530 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3530 Mechanical dental cleaner.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
49. Section 872.3580 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3580 Preformed gold denture tooth.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
50. Section 872.3670 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3670 Resin impression tray material.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
51. 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.
52. 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.
53. Section 872.3900 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3900 Posterior artificial tooth with a metal insert.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
54. Section 872.3910 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3910 Backing and facing for an artificial tooth.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
55. Section 872.4130 is amended by revising paragraph (b) to read
as follows:
Sec. 872.4130 Intraoral dental drill.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
56. Section 872.4535 is amended by revising paragraph (b) to read
as follows:
Sec. 872.4535 Dental diamond instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
57. Section 872.4620 is amended by revising paragraph (b) to read
as follows:
Sec. 872.4620 Fiber optic dental light.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
58. Section 872.4730 is amended by revising paragraph (b) to read
as follows:
Sec. 872.4730 Dental injecting needle.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
59. Section 872.5410 is amended by revising paragraph (b) to read
as follows:
Sec. 872.5410 Orthodontic appliance and accessories.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
60. Section 872.5525 is amended by revising paragraph (b) to read
as follows:
Sec. 872.5525 Preformed tooth positioner.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
61. Section 872.5550 is amended by revising paragraph (b)(1) to
read as follows:
Sec. 872.5550 Teething ring.
* * * * *
(b)(1) Classification. Class I if the teething ring does not
contain a fluid, such as water. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
* * * * *
62. Section 872.6030 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6030 Oral cavity abrasive polishing agent.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
63. 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.
64. Section 872.6140 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6140 Articulation paper.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
65. Section 872.6250 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6250 Dental chair and accessories.
* * * * *
(b) Classification. Class I. The dental chair without the operative
unit device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
66. Section 872.6300 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6300 Rubber dam and accessories.
* * * * *
(b) Classification. Class I. The accessories to the device, i.e.,
rubber dam clamp, rubber dam frame and forceps for a rubber dam clamp,
are exempt from the premarket notification procedures in subpart E of
part 807 of this chapter. 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, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
67. Section 872.6475 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6475 Heat source for bleaching teeth.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
68. Section 872.6510 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6510 Oral irrigation unit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
69. 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. The accessories tray to the dental
operative unit is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
70. Section 872.6865 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6865 Powered toothbrush.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
71. Section 872.6890 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6890 Intraoral dental wax.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
PART 874--EAR, NOSE, AND THROAT DEVICES
72. The authority citation for 21 CFR part 874 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).
73. Section 874.3375 is amended by revising paragraph (b) to read
as follows:
Sec. 874.3375 Battery-powered artificial larynx.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
74. Section 874.4750 is amended by revising paragraph (b) to read
as follows:
Sec. 874.4750 Laryngostroboscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
75. Section 874.5220 is amended by revising paragraph (b) to read
as follows:
Sec. 874.5220 Ear, nose, and throat drug administration device.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
76. Section 874.5800 is amended by revising paragraph (b) to read
as follows:
Sec. 874.5800 External nasal splint.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
77. The authority citation for 21 CFR part 876 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).
78. Section 876.5970 is amended by revising paragraph (b) to read
as follows:
Sec. 876.5970 Hernia support.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The device is exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
79. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,
360e, 360j, 3601, 371).
80. Section 878.1800 is amended by revising paragraph (b) to read
as follows:
Sec. 878.1800 Speculum and accessories.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
81. Section 878.3750 is amended by revising paragraph (b) to read
as follows:
Sec. 878.3750 External prosthesis adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
82. Section 878.3800 is amended by revising paragraph (b) to read
as follows:
Sec. 878.3800 External aesthetic restoration prosthesis.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. If the device is intended for use without an external
prosthesis adhesive to fasten it to the body, the device is exempt from
the current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
83. Section 878.3900 is amended by revising paragraph (b) to read
as follows:
Sec. 878.3900 Inflatable extremity splint.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
84. Section 878.4100 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4100 Organ bag.
* * * * *
(b) Classification. Class I. The intestinal organ bag device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
85. Section 878.4380 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4380 Drape adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
86. Section 878.4440 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4440 Eye pad.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
87. Section 878.4470 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4470 Surgeon's gloving cream.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
88. Section 878.4635 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4635 Ultraviolet lamp for tanning.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
89. Section 878.4660 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4660 Skin marker.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
90. Section 878.4700 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4700 Surgical microscope and accessories.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
91. Section 878.4730 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4730 Surgical skin degreaser or adhesive tape solvent.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
92. Section 878.4800 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4800 Manual surgical instrument for general use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
93. Section 878.4930 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4930 Suture retention device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
94. Section 878.4950 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4950 Manual operating table and accessories and manual
operating chair and accessories.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
95. Section 878.5900 is amended by revising paragraph (b) to read
as follows:
Sec. 878.5900 Nonpneumatic tourniquet.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
96. The authority citation for 21 CFR part 880 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).
97. Section 880.2400 is amended by revising paragraph (b) to read
as follows:
Sec. 880.2400 Bed-patient monitor.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
98. Section 880.2720 is amended by revising paragraph (b)(1) to
read as follows:
Sec. 880.2720 Patient scale.
* * * * *
(b) Classification. (1) Class I for a mechanical or battery powered
patient scale. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
99. Section 880.5180 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5180 Burn sheet.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
100. Section 880.5210 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5210 Intravascular catheter securement device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
101. Section 880.5240 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5240 Medical adhesive tape and adhesive bandage.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
102. Section 880.5630 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5630 Nipple shield.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
103. Section 880.5740 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5740 Suction snakebite kit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
104. Section 880.5780 is amended by revising paragraph (b)(2) to
read as follows:
Sec. 880.5780 Medical support stocking.
* * * * *
(b) * * *
(2) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The device is exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
105. Section 880.5950 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5950 Umbilical occlusion device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
106. Section 880.6060 is amended by revising paragraph (b) to read
as follows:
Sec. 880.6060 Medical disposable bedding.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
107. Section 880.6150 is amended by revising paragraph (b) to read
as follows:
Sec. 880.6150 Ultrasonic cleaner for medical instruments.
* * * * *
(b) Classification. Class I. The device, including any solutions
intended for use with the device for cleaning and sanitizing the
instruments, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
108. Section 880.6190 is amended by revising paragraph (b) to read
as follows:
Sec. 880.6190 Mattress cover for medical purposes.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
109. Section 880.6900 is amended by revising paragraph (b) to read
as follows:
Sec. 880.6900 Hand-carried stretcher.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The device is exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
PART 882--NEUROLOGICAL DEVICES
110. The authority citation for 21 CFR part 882 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).
111. Section 882.1430 is amended by revising paragraph (b) to read
as follows:
Sec. 882.1430 Electroencephalograph test signal generator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
112. Section 882.1700 is amended by revising paragraph (b) to read
as follows:
Sec. 882.1700 Percussor.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
113. Section 882.1925 is amended by revising paragraph (b) to read
as follows:
Sec. 882.1925 Ultrasonic scanner calibration test block.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
114. Section 882.4030 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4030 Skull plate anvil.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
115. Section 882.4125 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4125 Neurosurgical chair.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
116. Section 882.4190 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4190 Clip forming/cutting instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
117. Section 882.4200 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4200 Clip removal instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
118. Section 882.4215 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4215 Clip rack.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
119. Section 882.4440 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4440 Neurosurgical headrest.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
120. Section 882.4500 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4500 Cranioplasty material forming instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
121. Section 882.4525 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4525 Microsurgical instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
122. Section 882.4535 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4535 Nonpowered neurosurgical instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
123. Section 882.4600 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4600 Leukotome.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
124. Section 882.4900 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4900 Skullplate screwdriver.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 886--OPHTHALMIC DEVICES
125. The authority citation for 21 CFR part 886 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).
126. Section 886.1040 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1040 Ocular esthesiometer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
127. Section 886.1050 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1050 Adaptometer (biophotometer).
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
128. Section 886.1070 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1070 Anomaloscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
129. Section 886.1090 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1090 Haidlinger brush.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
130. Section 886.1140 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1140 Ophthalmic chair.
* * * * *
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from
the current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
131. Section 886.1160 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1160 Color vision plate illuminator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
132. Section 886.1250 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1250 Euthyscope.
* * * * *
(b) Classification. Class I for the battery powered device. The
battery powered device is exempt from premarket notification procedures
in subpart E of part 807 of this chapter. Class II for the AC-powered
device.
133. Section 886.1290 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1290 Fixation device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
134. Section 886.1340 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1340 Haploscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
135. Section 886.1350 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1350 Keratoscope.
* * * * *
(b) Classification. Class I. The AC-powered device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter only when the device does not include computer software in the
unit or topographers. The battery-powered device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The battery-powered device is also exempt from the current
good manufacturing practice regulations in part 820 of this chapter,
with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
136. Section 886.1425 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1425 Lens measuring instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
137. Section 886.1430 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1430 Ophthalmic contact lens radius measuring device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
138. Section 886.1435 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1435 Maxwell spot.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
139. Section 886.1450 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1450 Corneal radius measuring device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter only when the device does not include computer software in the
unit or topographers.
140. Section 886.1660 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1660 Gonioscopic prism.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
141. Section 886.1680 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1680 Ophthalmic projector.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
142. Section 886.1690 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1690 Pupillograph.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
143. Section 886.1700 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1700 Pupillometer.
* * * * *
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from
the current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
144. Section 886.1810 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1810 Tangent screen (campimeter).
* * * * *
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
145. Section 886.1860 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1860 Ophthalmic instrument stand.
(b) Classification. Class I. The AC-powered device and the battery-
powered device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
146. Section 886.1870 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1870 Stereoscope.
* * * * *
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
147. Section 886.1910 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1910 Spectacle dissociation test system.
* * * * *
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
148. Section 886.1945 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1945 Transilluminator.
* * * * *
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device. The battery-powered Class I device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
149. Section 886.4250 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4250 Ophthalmic electrolysis unit.
* * * * *
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device. The battery-powered Class I device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
150. Section 886.4350 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4350 Manual ophthalmic surgical instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
151. Section 886.4360 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4360 Ocular surgery irrigation device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
152. Section 886.4570 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4570 Ophthalmic surgical marker.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
153. Section 886.4750 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4750 Ophthalmic eye shield.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
154. Section 886.4855 is amended by revising paragraph (b) to read
as follows:
Sec. 886.4855 Ophthalmic instrument table.
* * * * *
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from
the current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
155. Section 886.5820 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5820 Closed-circuit television reading system.
* * * * *
(b) Classification. Class I. The AC-powered device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
156. Section 886.5840 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5840 Magnifying spectacles.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
157. Section 886.5842 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5842 Spectacle frame.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
158. Section 886.5844 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5844 Prescription spectacle lens.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
159. Section 886.5850 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5850 Sunglasses (nonprescription).
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter and the exemption applies only to sunglasses which:
(1) Transmit less than 1.0 percent UV-B radiation;
(2) Transmit less than 5.0 percent UV-A radiation;
(3) Meet impact resistance (21 CFR 801.410);
(4) Use nonflammable materials; and
(5) Limit claims to reduction of the risk age-related cataracts
and/or photokeratitis.
160. Section 886.5900 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5900 Electronic vision aid.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
161. Section 886.5915 is amended by revising paragraph (b) to read
as follows:
Sec. 886.5915 Optical vision aid.
* * * * *
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
PART 888--ORTHOPEDIC DEVICES
162. The authority citation for 21 CFR part 888 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).
163. Section 888.4200 is amended by revising paragraph (b) to read
as follows:
Sec. 888.4200 Cement dispenser.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
164. Section 888.4210 is amended by revising paragraph (b) to read
as follows:
Sec. 888.4210 Cement mixer 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.
165. Section 888.4230 is amended by revising paragraph (b) to read
as follows:
Sec. 888.4230 Cement ventilation tube.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
166. Section 888.4540 is amended by revising paragraph (b) to read
as follows:
Sec. 888.4540 Orthopedic manual surgical instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
167. Section 888.5940 is amended by revising paragraph (b) to read
as follows:
Sec. 888.5940 Cast component.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
PART 890--PHYSICAL MEDICINE DEVICES
168. The authority citation for 21 CFR part 890 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).
169. Section 890.1175 is amended by revising paragraph (b) to read
as follows:
Sec. 890.1175 Electrode cable.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The devices are also exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
170. Section 890.3100 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3100 Mechanical chair.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
171. Section 890.3750 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3750 Mechanical table.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
172. Section 890.3920 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3920 Wheelchair component.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
173. Section 890.3940 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3940 Wheelchair platform scale.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. 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, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
174. Section 890.5765 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5765 Pressure-applying device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 892--RADIOLOGY DEVICES
175. The authority citation for 21 CFR part 892 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).
176. Section 892.1130 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1130 Nuclear whole body counter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
177. Section 892.1350 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1350 Nuclear scanning bed.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter only when the device is labeled with weight limit, is used with
planar scanning only, and is not for diagnostic X-ray use.
178. Section 892.1640 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1640 Radiographic film marking system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
179. Section 892.5740 is amended by revising paragraph (b) to read
as follows:
Sec. 892.5740 Radionuclide teletherapy source.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
Dated: July 15, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17705 Filed 7-18-94; 11:43 am]
BILLING CODE 4160-01-P