[Federal Register Volume 61, Number 10 (Tuesday, January 16, 1996)] [Rules and Regulations] [Pages 1117-1126] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-418] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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