Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884,

886, 888, 890, and 892

[Docket No. 95N-0139]

RIN 0910-AA65

Medical Devices; Reclassification and Exemption 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 reclassifying 111

generic types of class II devices into class I based on new information

respecting such devices. FDA is also exempting the 111 generic types of

devices, and 11 already classified 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

[[Page 1118]]

the agency to make better use of its resources and thus better serve

the public. These devices will remain subject to current good

manufacturing practice (CGMP) regulations and other general controls.

This rulemaking is part of the President's and Vice President's

Reinventing Government effort.

DATES: Effective February 15, 1996. Beginning on February 15, 1996, 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: Melpomeni K. Jeffries, Center for

Devices and Radiological Health (HFZ-404), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

2186.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 28, 1995 (60 FR 38902), FDA issued

a proposed rule to reclassify 112 generic types of class II devices

into class I based on new information respecting such devices and to

exempt the 112 generic types of devices, and 12 already classified

generic types of class I devices, from the requirement of premarket

notification, with limitations. Interested persons were given until

October 11, 1995, to comment on the proposed rule.

II. Comments

During the comment period, FDA received three comments requesting

that various devices be added to the list of devices that the agency

was proposing to reclassify into class I and/or exempt from the

requirement of premarket notification. FDA is considering these

comments and will address them in a future issue of the Federal

Register.

FDA also received a comment stating that the proposed

reclassification and exemption for endoscope and accessories (21 CFR

876.1500) was too narrow. According to this comment, the

reclassification and exemption for endoscope and accessories should be

expanded to include additional endoscope accessories which the comment

felt meets the reclassification and exemption criteria. FDA is

finalizing the endoscope and accessories reclassification and exemption

as proposed. However, FDA is considering expanding the reclassification

and exemption for endoscope and accessories to include additional

endoscope accessories and FDA will address this device in a future

issue of the Federal Register.

FDA received three comments questioning the appropriateness of the

proposed reclassification and exemption for scented or scented

deodorized menstrual pads (21 CFR 884.5425) and the proposed exemption

for unscented menstrual pads (21 CFR 884.5435). All three comments

requested that the ``made from cotton or rayon'' limitation placed upon

the proposed reclassification into class I and the exemption from the

requirement of premarket notification be revised. In addition, two of

the comments questioned the proposed requirements for safety testing.

FDA is deferring action on these two devices in order to review these

comments more closely and to reevaluate whether the devices should be

reclassified and/or exempted from the requirement of premarket

notification, with limitations. The agency will address these devices

in a future issue of the Federal Register.

III. Conclusion

FDA received no comments opposing the reclassification into class I

of 111 of the 112 generic types of devices included in the proposed

rule. Moreover, the agency did not receive comments opposing the

proposed exemption from the requirements of premarket notification for

111 of these 112 generic types of devices, and 11 already classified

generic types of class I devices. For 111 of the 112 devices proposed

for reclassification into class I, the agency has concluded, based on

new information respecting such devices as described in the proposed

rule, that general controls will provide reasonable assurance of the

safety and effectiveness of these devices. For 122 of the 124 devices

for which exemptions have been proposed (including the 111 device types

being reclassified), 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

reclassification of 111 devices and the exemption from premarket

notification for 122 devices, including the 111 devices being

reclassified and 11 of the devices already classified in class I. All

of these devices remain subject to CGMP requirements and other general

controls under the statute.

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 or 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 would reduce a regulatory

burden by exempting manufacturers of devices subject to the rule from

the requirements of premarket notification, the agency certifies that

the 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 Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 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

862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890,

and 892 are amended as follows:

[[Page 1119]]

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

1. The authority citation for 21 CFR part 862 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 862.2230 is amended by revising paragraph (b) to read as

follows:

Sec. 862.2230- Chromatographic separation material for clinical use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

3. 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).

4. Section 866.2160 is amended by revising paragraph (b) to read as

follows:

Sec. 866.2160- Coagulase plasma.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

5. Section 866.3720 is amended by revising paragraph (b) to read as

follows:

Sec. 866.3720- Streptococcus spp. exoenzyme reagents.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

6. Section 866.5520 is amended by revising paragraph (b) to read as

follows:

Sec. 866.5520- Immunoglobulin G (Fab 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.

7. Section 866.5530 is amended by revising paragraph (b) to read as

follows:

Sec. 866.5530- Immunoglobulin G (Fc 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.

8. Section 866.5860 is amended by revising paragraph (b) to read as

follows:

Sec. 866.5860- Total spinal fluid 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

9. 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).

10. Section 868.1100 is amended by revising paragraph (b) to read

as follows:

Sec. 868.1100- Arterial blood sampling kit.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

11. Section 868.1575 is amended by revising paragraph (b) to read

as follows:

Sec. 868.1575- Gas collection vessel.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

12. Section 868.1870 is amended by revising paragraph (b) to read

as follows:

Sec. 868.1870- Gas volume calibrator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

13. Section 868.1975 is amended by revising paragraph (b) to read

as follows:

Sec. 868.1975- Water vapor analyzer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

14. Section 868.2300 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2300- Bourdon gauge flowmeter.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

15. Section 868.2320 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2320- Uncompensated thorpe tube flowmeter.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

16. Section 868.2340 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2340- Compensated thorpe tube flowmeter.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

17. Section 868.2350 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2350- Gas calibration flowmeter.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

18. Section 868.2610 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2610- Gas pressure gauge.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

19. Section 868.2620 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2620- Gas pressure calibrator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

20. Section 868.2700 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2700- Pressure regulator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

21. Section 868.2875 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2875- Differential pressure transducer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

22. Section 868.2885 is amended by revising paragraph (b) to read

as follows:

Sec. 868.2885- Gas flow transducer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

23. Section 868.2900 is amended by revising paragraph (b) to read

as follows:

[[Page 1120]]

Sec. 868.2900- Gas pressure transducer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

24. Section 868.5100 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5100- Nasopharyngeal airway.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

25. Section 868.5110 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5110- Oropharyngeal airway.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

26. Section 868.5240 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5240- Anesthesia breathing circuit.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

27. Section 868.5300 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5300- Carbon dioxide absorbent.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

28. Section 868.5310 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5310- Carbon dioxide absorber.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

29. Section 868.5320 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5320- Reservoir bag.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

30. Section 868.5375 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5375- Heat and moisture condenser (artificial nose).

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

31. Section 868.5460 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5460- Therapeutic humidifier for home use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

32. Section 868.5530 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5530- Flexible laryngoscope.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

33. Section 868.5540 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5540- Rigid laryngoscope.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

34. Section 868.5550 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5550- Anesthetic gas mask.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

35. Section 868.5570 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5570- Nonrebreathing mask.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

36. Section 868.5580 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5580- Oxygen mask.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

37. Section 868.5590 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5590- Scavenging mask.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

38. Section 868.5600 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5600- Venturi mask.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

39. Section 868.5770 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5770- Tracheal tube fixation device.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

40. Section 868.5780 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5780- Tube introduction forceps.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

41. Section 868.5790 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5790- Tracheal tube stylet.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

42. Section 868.5810 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5810- Airway connector.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

43. Section 868.5820 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5820- Dental protector.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

44. Section 868.5860 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5860- Pressure tubing 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 868.5975 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5975- Ventilator tubing.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

46. Section 868.5995 is amended by revising paragraph (b) to read

as follows:

Sec. 868.5995- Tee drain (water trap).

* * * * *

[[Page 1121]]

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

47. Section 868.6400 is amended by revising paragraph (b) to read

as follows:

Sec. 868.6400- Calibration gas.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

48. Section 868.6820 is amended by revising paragraph (b) to read

as follows:

Sec. 868.6820- Patient position support.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

49. Section 868.6885 is amended by revising paragraph (b) to read

as follows:

Sec. 868.6885- Medical gas yoke assembly.

* * * * *

(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

50. 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).

51. Section 870.2390 is amended by revising paragraph (b) to read

as follows:

Sec. 870.2390- Phonocardiograph.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

52. Section 870.2600 is amended by revising paragraph (b) to read

as follows:

Sec. 870.2600- Signal isolation system.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

53. Section 870.2620 is amended by revising paragraph (b) to read

as follows:

Sec. 870.2620- Line isolation monitor.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

54. Section 870.2640 is amended by revising paragraph (b) to read

as follows:

Sec. 870.2640- Portable leakage current alarm.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

55. Section 870.2810 is amended by revising paragraph (b) to read

as follows:

Sec. 870.2810- Paper chart recorder.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

56. Section 870.3650 is amended by revising paragraph (b) to read

as follows:

Sec. 870.3650- Pacemaker polymeric mesh bag.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

57. Section 870.3670 is amended by revising paragraph (b) to read

as follows:

Sec. 870.3670- Pacemaker charger.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

58. Section 870.3690 is amended by revising paragraph (b) to read

as follows:

Sec. 870.3690- Pacemaker test magnet.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

59. Section 870.3935 is amended by revising paragraph (b) to read

as follows:

Sec. 870.3935- Prosthetic heart valve holder.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

60. Section 870.3945 is amended by revising paragraph (b) to read

as follows:

Sec. 870.3945- Prosthetic heart valve sizer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 872--DENTAL DEVICES

61. 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).

62. Section 872.1840 is amended by revising paragraph (b) to read

as follows:

Sec. 872.1840- Dental X-ray position indicating device.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

63. Section 872.1850 is amended by revising paragraph (b) to read

as follows:

Sec. 872.1850- Lead-lined position indicator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

64. Section 872.4630 is amended by revising paragraph (b) to read

as follows:

Sec. 872.4630- Dental operating light.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

65. Section 872.6390 is amended by revising paragraph (b) to read

as follows:

Sec. 872.6390- Dental floss.

* * * * *

(b) Classification. Class I. If the device is made of inert

materials and is not coated or impregnated with chemicals intended to

provide a therapeutic benefit or interact with tissues of the oral

cavity, it is exempt from the premarket notification procedures in

Subpart E of Part 807 of this chapter.

PART 874--EAR, NOSE, AND THROAT DEVICES-

66. 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).

67. Section 874.1060 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1060- Acoustic chamber for audiometric testing.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

68. Section 874.1080 is amended by revising paragraph (b) to read

as follows:

Sec. 874.1080- Audiometer calibration set

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

[[Page 1122]]

69. Section 874.4140 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4140- Ear, nose, and throat bur.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

70. Section 874.4175 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4175- Nasopharyngeal catheter.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

71. Section 874.4350 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4350- Ear, nose, and throat fiberoptic light source and

carrier.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

72. Section 874.4770 is amended by revising paragraph (b) to read

as follows:

Sec. 874.4770- Otoscope.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter only when used in the external ear canal.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

73. The authority citation for 21 CFR part 876 is revised 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).

74. Section 876.1075 is amended by revising paragraph (b) to read

as follows:

Sec. 876.1075- Gastroenterology-urology biopsy instrument.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the biopsy forceps cover and the non-electric

biopsy forceps. The devices subject to this paragraph (b)(2) are exempt

from the premarket notification procedures in subpart E of part 807 of

this chapter.

75. Section 876.1400 is amended by revising paragraph (b) to read

as follows:

Sec. 876.1400- Stomach pH electrode.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

76. Section 876.1500 is amended by revising paragraph (b) to read

as follows:

Sec. 876.1500- Endoscope and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the photographic accessories for endoscope,

miscellaneous bulb adapter for endoscope, binocular attachment for

endoscope, eyepiece attachment for prescription lens, teaching

attachment, inflation bulb, measuring device for panendoscope,

photographic equipment for physiologic function monitor, special lens

instrument for endoscope, smoke removal tube, rechargeable battery box,

pocket battery box, bite block for endoscope, and cleaning brush for

endoscope. The devices subject to this paragraph (b)(2) are exempt from

the premarket notification procedures in subpart E of part 807 of this

chapter.

77. Section 876.1800 is amended by revising paragraph (b) to read

as follows:

Sec. 876.1800- Urine flow or volume measuring system.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the disposable, nonelectrical urine flow rate

measuring device, and nonelectrical urinometer. The devices subject to

this paragraph (b)(2) are exempt from the premarket notification

procedures in subpart E of part 807 of this chapter.

78. Section 876.4590 is amended by revising paragraph (b) to read

as follows:

Sec. 876.4590- Interlocking urethral sound.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

79. Section 876.4890 is amended by revising paragraph (b) to read

as follows:

Sec. 876.4890- Urological table and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards) for the

electrically powered urological table and accessories.

(2) Class I for the manually powered table and accessories, and for

stirrups for electrically powered table. The device subject to this

paragraph (b)(2) is exempt from the premarket notification procedures

in subpart E of part 807 of this chapter.

80. Section 876.5090 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5090- Suprapubic urological catheter and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the catheter punch instrument, nondisposable

cannula and trocar, and gastro-urological trocar. The devices subject

to this paragraph (b)(2) are exempt from the premarket notification

procedures in subpart E of part 807 of this chapter.

81. Section 876.5130 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5130- Urological catheter and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the ureteral stylet (guidewire), stylet for gastro-

urological catheter, ureteral catheter adapter, ureteral catheter

connector, and ureteral catheter holder. The devices subject to this

paragraph (b)(2) are exempt from the premarket notification procedures

in subpart E of part 807 of this chapter.

82. Section 876.5450 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5450- Rectal dilator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

83. Section 876.5520 is amended by revising paragraph (b) to read

as follows:

Sec. 876.5520- Urethral dilator.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the urethrometer, urological bougie, filiform and

filiform follower, and metal or plastic urethral sound. The devices

subject to this paragraph (b)(2) are exempt from the premarket

notification procedures in subpart E of part 807 of this chapter.

84. Section 876.5540 is amended by revising paragraphs (b)(3) and

by adding new paragraph (b)(4) to read as follows:

Sec. 876.5540- Blood access device and accessories.

* * * * *

(b) Classification. * * *

(3) Class II (performance standards) for accessories for both the

implanted and the nonimplanted blood access devices not listed in

paragraph (b)(4) of this section.

(4) Class I for the cannula clamp, disconnect forceps, crimp plier,

tube plier, crimp ring, and joint ring, accessories for both the

implanted and nonimplanted blood access device. The devices subject to

this paragraph (b)(4) are exempt from the premarket notification

procedures in subpart E of part 807 of this chapter.

[[Page 1123]]

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

85. 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).

86. Section 878.4450 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4450- Nonabsorbable gauze for internal use.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

87. Section 878.4810 is amended by revising paragraph (b) to read

as follows:

Sec. 878.4810- Laser surgical instrument for use in general and

plastic surgery and in dermatology.

* * * * *

(b) Classification. (1) Class II.

(2) Class I for special laser gas mixtures used as a lasing medium

for this class of lasers. The devices subject to this paragraph (b)(2)

are exempt from the premarket notification procedures in subpart E of

part 807 of this chapter.

88. Section 878.5350 is amended by revising paragraph (b) to read

as follows:

Sec. 878.5350- Needle-type epilator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

89. Section 878.5910 is amended by revising paragraph (b) to read

as follows:

Sec. 878.5910- Pneumatic 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

90. The authority citation for 21 CFR 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).

91. Section 880.2720 is amended by revising paragraph (b) to read

as follows:

Sec. 880.2720- Patient scale.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

92. Section 880.2900 is amended by revising paragraph (b) to read

as follows:

Sec. 880.2900- Clinical color change thermometer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

93. Section 880.5560 is amended by revising paragraph (b) to read

as follows:

Sec. 880.5560- Temperature regulated water mattress.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

94. Section 880.6320 is amended by revising paragraph (b) to read

as follows:

Sec. 880.6320- AC-powered medical examination light.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 882--NEUROLOGICAL DEVICES

95. 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).

96. Section 882.1410 is amended by revising paragraph (b) to read

as follows:

Sec. 882.1410- Electroencephalograph electrode/lead tester.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

97. Section 882.4325 is amended by revising paragraph (b) to read

as follows:

Sec. 882.4325- Cranial drill handpiece (brace).

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

98. The authority citation for 21 CFR part 884 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).

99. Section 884.1550 is revised to read as follows:

Sec. 884.1550- Amniotic fluid sampler (amniocentesis tray).

(a) Identification. The amniotic fluid sampler (amniocentesis tray)

is a collection of devices used to aspirate amniotic fluid from the

amniotic sac via a transabdominal approach. Components of the

amniocenteses tray include a disposable 3 inch 20 gauge needle with

stylet and a 30 cc. syringe, as well as the various sample collection

accessories, such as vials, specimen containers, medium, drapes, etc.

The device is used at 16-18 weeks gestation for antepartum diagnosis of

certain congenital abnormalities or anytime after 24 weeks gestation

when used to assess fetal maturity.

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

100. Section 884.1640 is amended by revising paragraph (b) to read

as follows:

Sec. 884.1640- Culdoscope and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).-

(2) Class I for culdoscope accessories that are not part of a

specialized instrument or device delivery system; do not have adapters,

connectors, channels, or do not have portals for electrosurgical,

laser, or other power sources. Such culdoscope accessory instruments

include: lens cleaning brush, biopsy brush, clip applier (without

clips), applicator, cannula (without trocar or valves), ligature

carrier/needle holder, clamp/hemostat/grasper, curette, instrument

guide, ligature passing and knotting instrument, suture needle (without

suture), retractor, mechanical (noninflatable), snare, stylet, forceps,

dissector, mechanical (non-inflatable) scissors, and suction/irrigation

probe. The devices subject to this paragraph (b)(2) are exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

101. Section 884.1690 is amended by revising paragraph (b) to read

as follows:

Sec. 884.1690- Hysteroscope and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for hysteroscope accessories that are not part of a

specialized instrument or device delivery system; do not have adapters,

connectors, channels, or do not have portals for electrosurgical,

laser, or other power sources. Such hysteroscope accessory instruments

include: lens cleaning brush, cannula (without trocar or valves),

clamp/hemostat/grasper,

[[Page 1124]]

curette, instrument guide, forceps, dissector, mechanical

(noninflatable), and scissors. The devices subject to this paragraph

(b)(2) are exempt from the premarket notification procedures in subpart

E of part 807 of this chapter.

102. Section 884.1700 is amended by revising paragraph (b) to read

as follows:

Sec. 884.1700- Hysteroscopic insufflator.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for tubing and tubing/filter fits which only include

accessory instruments which are not used to effect intrauterine access

e.g. hysteroscopic introducer sheaths, etc.; and single-use tubing kits

used for only intrauterine insufflation. The devices subject to this

paragraph (b)(2) are exempt from the premarket notification procedures

in subpart E of part 807 of this chapter.

103. Section 884.1720 is amended by revising paragraph (b) to read

as follows:

Sec. 884.1720- Gynecologic laparoscope and accessories.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for gynecologic laparoscope accessories that are not

part of a specialized instrument or device delivery system, do not have

adapters, connector channels, or do not have portals for

electrosurgical, lasers, or other power sources. Such gynecologic

laparoscope accessory instruments include: the lens cleaning brush,

biopsy brush, clip applier (without clips), applicator, cannula

(without trocar or valves), ligature carrier/needle holder, clamp/

hemostat/grasper, curette, instrument guide, ligature passing and

knotting instrument, suture needle (without suture), retractor,

mechanical (noninflatable), snare, stylet, forceps, dissector,

mechanical (noninflatable), scissors, and suction/irrigation probe. The

devices subject to this paragraph (b)(2) are exempt from the premarket

notification procedures in subpart E of part 807 of this chapter.

104. Section 884.1730 is amended by revising paragraph (b) to read

as follows:

Sec. 884.1730- Laparoscopic insufflator.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for tubing and tubing/filter kits which include

accessory instruments which are not used to effect intra-abdominal

access, Verres needles etc.; and single-use tubing kits used for only

intra-abdominal insufflation (pneumoperitoneum). The devices subject to

this paragraph (b)(2) are exempt from the premarket notification

procedures in subpart E of part 807 of this chapter.

105. Section 884.4530 is amended by revising paragraph (b) to read

as follows:

Sec. 884.4530- Obstetric-gynecological specialized manual instrument.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the amniotome, uterine curette, cervical dilator

(fixed-size bougies), cerclage needle, IUD remover, uterine sound, and

gynecological biopsy forceps. The devices subject to this paragraph

(b)(2) are exempt from the premarket notification procedures in subpart

E of part 807 of this chapter.

106. Section 884.5150 is amended by revising paragraph (b) to read

as follows:

Sec. 884.5150- Nonpowered breast pump.

* * * * *

(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 using either a bulb or telescoping mechanism

which does not develop more than 250 mm Hg suction, and the device

materials that contact breast or breast milk do not produce

cytotoxicity, irritation, or sensitization effects.

107. Section 884.5900 is amended by revising paragraph (b) to read

as follows:

Sec. 884.5900- Therapeutic vaginal douche apparatus.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I if the device is operated by gravity feed. Devices

subject to this paragraph (b)(2) are exempt from the premarket

notification procedures in subpart E of part 807 of this chapter.

PART 886--OPHTHALMIC DEVICES

108. The authority citation for 21 CFR 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).

109. Section 886.1405 is amended by revising paragraph (b) to read

as follows:

Sec. 886.1405- Ophthalmic trial lens set.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

110. Section 886.1750 is amended by revising paragraph (b) to read

as follows:

Sec. 886.1750- Skiascopic rack.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

111. Section 886.1760 is amended by revising paragraph (b) to read

as follows:

Sec. 886.1760- Ophthalmic refractometer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

112. Section 886.3200 is revised to read as follows:

Sec. 886.3200- Artificial eye.

(a) Identification. An artificial eye is a device resembling the

anterior portion of the eye, usually made of glass or plastic, intended

to be inserted in a patient's eye socket anterior to an orbital

implant, or the eviscerated eyeball, for cosmetic purposes. The device

is not intended to be implanted.

(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 made from the same materials, has the same

chemical composition, and uses the same manufacturing processes as

currently legally marketed devices.

PART 888--ORTHOPEDIC DEVICES

113. 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).

114. Section 888.1100 is amended by revising paragraph (b) to read

as follows:

Sec. 888.1100- Arthroscope.

* * * * *

(b) Classification. (1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments:

cannulas, currettes, drill guides, forceps, gouges, graspers, knives,

obturators, osteotomes, probes, punches, rasps, retractors, rongeurs,

suture passers, suture knotpushers, suture punches, switching rods, and

trocars. The devices subject to this paragraph (b)(2) are exempt from

the premarket notification procedures in subpart E of part 807 of this

chapter.

115. Section 888.3000 is amended by revising paragraph (b) to read

as follows:

Sec. 888.3000- Bone cap.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

[[Page 1125]]

116. Section 888.5960 is amended by revising paragraph (b) to read

as follows:

Sec. 888.5960- Cast removal instrument.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

PART 890--PHYSICAL MEDICINE DEVICES

117. 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).

118. Section 890.1575 is amended by revising paragraph (b) to read

as follows:

Sec. 890.1575- Force-measuring platform.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

119. Section 890.1600 is amended by revising paragraph (b) to read

as follows:

Sec. 890.1600- Intermittent pressure measurement system.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

120. Section 890.1615 is amended by revising paragraph (b) to read

as follows:

Sec. 890.1615- Miniature pressure transducer.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

121. Section 890.3175 is amended by revising paragraph (b) to read

as follows:

Sec. 890.3175- Flotation cushion.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

122. Section 890.3760 is amended by revising paragraph (b) to read

as follows:

Sec. 890.3760- Powered table.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

123. Section 890.5380 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5380- Powered exercise equipment.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

124. Section 890.5410 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5410- Powered finger exerciser.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

125. Section 890.5660 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5660- Therapeutic massager.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

126. Section 890.5925 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5925- Traction accessory.

* * * * *

(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.

127. Section 890.5940 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5940- Chilling unit.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

128. Section 890.5950 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5950- Powered heating unit.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

129. Section 890.5975 is amended by revising paragraph (b) to read

as follows:

Sec. 890.5975- Therapeutic vibrator.

* * * * *

(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

130. 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).

131. Section 892.1700 is amended by revising paragraph (b) to read

as follows:

Sec. 892.1700- Diagnostic X-ray high voltage generator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

132. Section 892.1760 is amended by revising paragraph (b) to read

as follows:

Sec. 892.1760- Diagnostic X-ray tube housing assembly.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

133. Section 892.1770 is amended by revising paragraph (b) to read

as follows:

Sec. 892.1770- Diagnostic X-ray tube mount.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

134. Section 892.1830 is amended by revising paragraph (b) to read

as follows:

Sec. 892.1830- Radiologic patient cradle.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

135. Section 892.1880 is amended by revising paragraph (b) to read

as follows:

Sec. 892.1880- Wall-mounted radiographic cassette holder.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

136. Section 892.5780 is amended by revising paragraph (b) to read

as follows:

Sec. 892.5780- Light beam patient position indicator.

* * * * *

(b) Classification. Class I. The device is exempt from the

premarket notification procedures in subpart E of part 807 of this

chapter.

137. Section 892.6500 is amended by revising paragraph (b) to read

as follows:

Sec. 892.6500- Personnel protective shield.

* * * * *

(b) Classification. Class I. If the device's labeling specifies the

lead equivalence, it is exempt from the

[[Page 1126]]

premarket notification procedures in subpart E of part 807 of this

chapter.

Dated: January 5, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96-418 Filed 1-11-96; 2:00 pm]

BILLING CODE 4160-01-F