Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.
Fed Regist. 1998 Apr 27; 63(80 Pt 1):20530-3.FR

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to 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 tissue 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 ApprovalEquipment SafetyForms and Records ControlIndustryTime FactorsUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10179319

Citation

"Medical Devices; 30-day Notices and 135-day PMA (premarket Approval Application) Supplement review--FDA. Direct Final Rule." Federal Register, vol. 63, no. 80 Pt 1, 1998, pp. 20530-3.

Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule. Fed Regist. 1998;63(80 Pt 1):20530-3.

(1998). Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule. Federal Register, 63(80 Pt 1), 20530-3.

Medical Devices; 30-day Notices and 135-day PMA (premarket Approval Application) Supplement review--FDA. Direct Final Rule. Fed Regist. 1998 Apr 27;63(80 Pt 1):20530-3. PubMed PMID: 10179319.

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

TY - JOUR T1 - Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule. PY - 1998/4/3/pubmed PY - 1998/4/3/medline PY - 1998/4/3/entrez SP - 20530 EP - 3 JF - Federal register JO - Fed Regist VL - 63 IS - 80 Pt 1 N2 - The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to 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 tissue 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/10179319/Medical_devices DB - PRIME DP - Unbound Medicine ER -

Tags

Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.Fed Regist. 1998 Apr 27; 63(80 Pt 1):20530-3.FR