Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule.
Fed Regist. 1998 Sep 29; 63(188):51825-7.FR

Abstract

The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). 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 ApprovalIndustryUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10185812

Citation

"Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of devices--FDA. Direct Final Rule." Federal Register, vol. 63, no. 188, 1998, pp. 51825-7.

Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule. Fed Regist. 1998;63(188):51825-7.

(1998). Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule. Federal Register, 63(188), 51825-7.

Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of devices--FDA. Direct Final Rule. Fed Regist. 1998 Sep 29;63(188):51825-7. PubMed PMID: 10185812.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule. PY - 1998/9/2/pubmed PY - 1998/9/2/medline PY - 1998/9/2/entrez SP - 51825 EP - 7 JF - Federal register JO - Fed Regist VL - 63 IS - 188 N2 - The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). 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/10185812/Medical_devices DB - PRIME DP - Unbound Medicine ER -

Tags