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 D09002ee1bdff5641 D09002ee1bdff56fc 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 regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule. 63 FR 42229 https://www.govinfo.gov/app/details/FR-1998-08-07/98-21091 98-21091 fr07au98-20 4160-01-F Docket No. 98N-0439 https://www.govinfo.gov/app/details/FR-1998-08-07/98-21091 https://www.govinfo.gov/content/pkg/FR-1998-08-07/html/98-21091.htm https://www.govinfo.gov/content/pkg/FR-1998-08-07/pdf/98-21091.pdf 5 p. 42229 42233 63 FR 42229 Title 21 Part 806 21 CFR Part 806 Medical Devices; Reports of Corrections and Removals; Federal Register Vol. 63, Issue RULE 98-21091 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1998-12-21 1998-10-21 Docket No. 98N-0439 4160-01-F 98-21091 Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

The regulation is effective December 21, 1998. Submit written comments on or before October 21, 1998. Submit written comments on the information collection provisions on or before October 6, 1998. If FDA receives no significant adverse comment within the specified comment period, the agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. Rosa M. Gilmore, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20857, 301-827-2970. SUPPLEMENTARY INFORMATION: Vol. 63, no. 152 Office of the Federal Register, National Archives and Records Administration 1998-08-07 continuing daily deposited born digital 375 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-08-07 P0b002ee180a5315e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07au98 https://www.govinfo.gov/app/details/FR-1998-08-07 https://www.govinfo.gov/content/pkg/FR-1998-08-07/pdf/FR-1998-08-07.pdf fdlp 42201 42565 DGPO 2010-09-24 2023-05-06 FR-1998-08-07 machine generated eng FR FR-1998-08-07 63 152