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 1998_register executive 2010-09-24 article Rules and Regulations D09002ee1bdfecadd D09002ee1bdfecb71 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 codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA). EFFECTIVE DATE: November 3, 1998. 63 FR 59222 https://www.govinfo.gov/app/details/FR-1998-11-03/98-29189 98-29189 fr03no98-8 4160-01-F Docket No. 98-0015 https://www.govinfo.gov/app/details/FR-1998-11-03/98-29189 https://www.govinfo.gov/content/pkg/FR-1998-11-03/html/98-29189.htm https://www.govinfo.gov/content/pkg/FR-1998-11-03/pdf/98-29189.pdf 10 p. 59222 59231 63 FR 59222 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 876 21 CFR Part 876 Title 21 Part 880 21 CFR Part 880 Title 21 Part 882 21 CFR Part 882 Title 21 Part 886 21 CFR Part 886 Title 21 Part 890 21 CFR Part 890 Title 21 Part 892 21 CFR Part 892 Medical Devices; Exemptions From Premarket Notification; Class II Devices; Federal Register Vol. 63, Issue RULE 98-29189 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 98-0015 4160-01-F 98-29189 Final rule.

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA). EFFECTIVE DATE: November 3, 1998.

November 3, 1998. 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. 63, no. 212 Office of the Federal Register, National Archives and Records Administration 1998-11-03 continuing daily deposited born digital 265 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-11-03 P0b002ee180a4dfbe 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03no98 https://www.govinfo.gov/app/details/FR-1998-11-03 https://www.govinfo.gov/content/pkg/FR-1998-11-03/pdf/FR-1998-11-03.pdf fdlp 59203 59455 DGPO 2010-09-24 2023-05-06 FR-1998-11-03 machine generated eng FR FR-1998-11-03 63 212