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Medical devices; reports of corrections and removals--FDA. Direct final rule.
Fed Regist. 1998 Aug 07; 63(152):42229-33.FR

Abstract

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.

MeSH

Device ApprovalForms and Records ControlHumansIndustryProduct Surveillance, PostmarketingRiskSafetyUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10181725

Citation

"Medical Devices; Reports of Corrections and removals--FDA. Direct Final Rule." Federal Register, vol. 63, no. 152, 1998, pp. 42229-33.
Medical devices; reports of corrections and removals--FDA. Direct final rule. Fed Regist. 1998;63(152):42229-33.
(1998). Medical devices; reports of corrections and removals--FDA. Direct final rule. Federal Register, 63(152), 42229-33.
Medical Devices; Reports of Corrections and removals--FDA. Direct Final Rule. Fed Regist. 1998 Aug 7;63(152):42229-33. PubMed PMID: 10181725.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Medical devices; reports of corrections and removals--FDA. Direct final rule. PY - 1998/7/12/pubmed PY - 1998/7/12/medline PY - 1998/7/12/entrez SP - 42229 EP - 33 JF - Federal register JO - Fed Regist VL - 63 IS - 152 N2 - 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. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10181725/Medical_devices DB - PRIME DP - Unbound Medicine ER -