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 2000_register executive 2010-09-23 article Rules and Regulations D09002ee1bdfb6ab6 D09002ee1bdfb6b37 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 amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. 65 FR 2296 https://www.govinfo.gov/app/details/FR-2000-01-14/00-884 00-884 fr14ja00-10 4160-01-F Docket No. 98N-0009 https://www.govinfo.gov/app/details/FR-2000-01-14/00-884 https://www.govinfo.gov/content/pkg/FR-2000-01-14/html/00-884.htm https://www.govinfo.gov/content/pkg/FR-2000-01-14/pdf/00-884.pdf 28 p. 2296 2323 65 FR 2296 Title 21 Part 862 21 CFR Part 862 Title 21 Part 864 21 CFR Part 864 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 Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I; Federal Register Vol. 65, Issue RULE 00-884 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2000-02-14 Docket No. 98N-0009 4160-01-F 00-884 Final rule.

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.

This regulation is effective February 14, 2000. Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 1190. Vol. 65, no. 10 Office of the Federal Register, National Archives and Records Administration 2000-01-14 continuing daily deposited born digital 249 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2000-01-14 P0b002ee1809f86ca 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14ja00 https://www.govinfo.gov/app/details/FR-2000-01-14 https://www.govinfo.gov/content/pkg/FR-2000-01-14/pdf/FR-2000-01-14.pdf fdlp 2281 2519 DGPO 2010-09-23 2023-05-05 FR-2000-01-14 machine generated eng FR FR-2000-01-14 65 10