[Federal Register Volume 59, Number 234 (Wednesday, December 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30025]
[[Page Unknown]]
[Federal Register: December 7, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 880, 882,
886, 888, 890, and 892
[Docket No. 94M-0260]
Medical Devices; Exemptions From Premarket Notification for Certain
Classified Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is exempting 148
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. The exemptions allow the agency to make better use of its
resources and thus better serve the public.
DATES: Effective January 6, 1995. Beginning on January 6, 1995, all
device manufacturers who have 510(k) submissions pending FDA review for
devices falling within a generic category which is subject to this
rule, will receive a letter stating that the device is exempt from the
premarket notification requirements of the act.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4765 ext. 157.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 21, 1994 (59 FR 37378), FDA issued
a proposed rule to exempt 164 generic types of class I devices from the
requirement of premarket notification, with limitations. Interested
persons were given until October 19, 1994 to comment on the proposed
rule.
II. Comments
During the comment period, FDA received comments requesting that
various devices be added to the list of devices that the agency was
proposing be exempt from the requirement of premarket notification. The
agency also received comments requesting that existing exemptions from
the requirement of premarket notification for several devices, when
made of certain materials, be expanded to include all devices within
the classification, regardless of material composition. FDA is
considering these comments and will address them in a future issue of
the Federal Register.
Several comments requested that certain devices proposed for
exemption from premarket notification also be exempted from the
requirements of current good manufacturing practices (CGMP's) and
records and reports. FDA has decided not to grant these additional
exemptions at this time. Pursuant to 21 CFR 820.1(d), any person
petitioning for an exemption from any device CGMP requirement is
required to follow the procedures set forth in 21 CFR 10.30.
Accordingly, the devices listed in this final rule as exempt from
premarket notification continue to be subject to applicable CGMP
requirements. FDA believes that compliance with CGMP's is necessary in
order to ensure adequate protection of the public health.
III. Conclusion
Several comments questioned the appropriateness of the proposed
exemptions for a small number of the devices. In addition, FDA is
reconsidering the appropriateness or scope of the proposed exemptions
for several devices included in the proposed rule. Therefore, FDA is
deferring action on the following 16 devices in order to review these
comments and to reevaluate whether certain of the devices should be
exempted from the requirement of premarket notification.
Table 1
------------------------------------------------------------------------
CFR 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.
864.2280..... Cultured animal and human cells.
866.5570..... Lactoferrin immunological test system.
868.5620..... Breathing mouthpiece.
868.5675..... Rebreathing device.
868.5700..... Nonpowered oxygen tent.
872.3740..... Retentive and splinting pin.
872.3810..... Root canal post.
872.6100..... Anesthetic warmer.
886.5850..... Sunglasses (nonprescription).
------------------------------------------------------------------------
FDA will address these devices in a future issue of the Federal
Register.
FDA received no adverse comments on 148 of the devices that it
proposed be exempted from the requirement of premarket notification.
For these 148 devices, FDA has concluded 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. Thus, FDA is
finalizing the exemptions for these 148 devices from premarket
notification procedures.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule reduces a regulatory burden
by exempting manufacturers of devices subject to the final rule from
the requirements of premarket notification, the agency certifies that
the final rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
List of Subjects
21 CFR Part 864
Blood, Medical devices, Packaging and containers.
21 CFR Parts 868, 870, 872, 874, 876, 878, 880, 882, 888, and 890
Medical devices.
21 CFR Part 866
Biologics, Laboratories, Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
21 CFR Part 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 886, 888, 890, and
892 are amended as follows:
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Section 866.5540 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5540 Immunoglobulin 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.
14. Section 866.5700 is amended by revising paragraph (b) to read
as follows:
Sec. 866.5700 Whole human plasma or 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
15. 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).
16. 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.
17. 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.
PART 870--CARDIOVASCULAR DEVICES
18. 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).
19. Section 870.1875 is amended by revising paragraph (a)(2) to
read as follows:
Sec. 870.1875 Stethoscope.
(a) * * *
(2) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
* * * * *
PART 872--DENTAL DEVICES
20. 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).
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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 of this
chapter.
27. 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.
28. 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.
29. 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.
30. 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.
31. 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.
32. Section 872.3450 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3450 Ethylene oxide homopolymer and/or karaya denture
adhesive.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
33. 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.
34. 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.
35. Section 872.3530 is amended by revising paragraph (b) to read
as follows:
Sec. 872.3530 Mechanical denture cleaner.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
36. Section 872.3580 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.
37. 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.
38. 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.
39. 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.
40. 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.
41. 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.
42. 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.
43. 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.
44. 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.
45. 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.
46. 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.
* * * * *
47. 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.
48. 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.
49. 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.
50. 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.
51. 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.
52. 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.
53. 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.
54. 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.
55. 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
56. 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).
57. 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.
58. 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.
59. 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.
60. 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
61. 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).
62. 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
63. 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, 360l, 371).
64. 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.
65. 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.
66. 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.
67. 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.
68. 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.
69. 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.
70. 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.
71. 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.
72. 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.
73. 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.
74. 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.
75. 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.
76. 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.
77. 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.
78. 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.
79. 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
80. 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).
81. 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.
82. 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.
* * * * *
83. 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.
84. Section 880.5210 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5210 Intravascular catheter securement device.
* * * * *
(b) Classification. Classs I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
85. 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.
86. 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.
87. 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.
88. 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.
89. 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.
90. 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.
91. 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.
92. 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 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.
93. 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
94. 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).
95. 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.
96. 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.
97. 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.
98. 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.
99. 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.
100. 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.
101. 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.
102. 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.
103. 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.
104. 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.
105. 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.
106. 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.
107. 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.
108. 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
109. 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).
110. 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.
111. 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.
112. 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.
113. 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.
114. 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.
115. 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.
116. 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.
117. 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.
118. 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.
119. 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. 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.
120. 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.
121. 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.
122. 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.
123. 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.
124. 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.
125. 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.
126. 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.
127. 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.
128. 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.
129. 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 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.
130. 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.
131. 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.
132. 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.
133. 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.
134. 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 only when the device meets the ANSI standard on optic radiation
limits.
135. 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.
136. 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.
137. 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.
138. 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.
139. 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.
140. 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.
141. 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.
142. 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.
143. 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.
144. 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
145. 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).
146. 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.
147. 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.
148. 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.
149. 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.
150. 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
151. 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).
152. 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.
153. 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.
154. 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.
155. 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.
156. 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.
157. 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
158. 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).
159. 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.
160. 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.
161. 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.
162. 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: November 30, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-30025 Filed 12-2-94; 12:01 pm]
BILLING CODE 4160-01-P
