United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1996_register executive 2010-09-24 article Rules and Regulations D09002ee1be0532ff D09002ee1be053310 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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 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. 61 FR 1117 https://www.govinfo.gov/app/details/FR-1996-01-16/96-418 96-418 fr16ja96-5 RIN 0910-AA65 4160-01-F Docket No. 95N-0139 https://www.govinfo.gov/app/details/FR-1996-01-16/96-418 https://www.govinfo.gov/content/pkg/FR-1996-01-16/html/96-418.htm https://www.govinfo.gov/content/pkg/FR-1996-01-16/pdf/96-418.pdf 10 p. 1117 1126 61 FR 1117 Title 21 Part 862 21 CFR Part 862 Title 21 Part 866 21 CFR Part 866 Title 21 Part 868 21 CFR Part 868 Title 21 Part 870 21 CFR Part 870 Title 21 Part 872 21 CFR Part 872 Title 21 Part 874 21 CFR Part 874 Title 21 Part 876 21 CFR Part 876 Title 21 Part 878 21 CFR Part 878 Title 21 Part 880 21 CFR Part 880 Title 21 Part 882 21 CFR Part 882 Title 21 Part 884 21 CFR Part 884 RIN 0910-AA65 Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices; Federal Register Vol. 61, Issue RULE 96-418 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1996-02-15 Docket No. 95N-0139 4160-01-F 96-418 Final rule.

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 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.

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. Melpomeni K. Jeffries, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 2186. Vol. 61, no. 10 Office of the Federal Register, National Archives and Records Administration 1996-01-16 continuing daily deposited born digital 48 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1996-01-16 P0b002ee180a2865f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16ja96 https://www.govinfo.gov/app/details/FR-1996-01-16 https://www.govinfo.gov/content/pkg/FR-1996-01-16/pdf/FR-1996-01-16.pdf fdlp 1109 1146 DGPO 2010-09-24 2023-05-07 FR-1996-01-16 machine generated eng FR FR-1996-01-16 61 10