[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