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Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule.
Fed Regist. 1998 May 12; 63(91):26069-77.FR

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. 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 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 a significant adverse comment and withdraws this direct final rule.

MeSH

Device ApprovalEquipment FailureEquipment SafetyHumansIatrogenic DiseaseInformation ServicesProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10179334

Citation

"Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor reporting--FDA. Direct Final Rule." Federal Register, vol. 63, no. 91, 1998, pp. 26069-77.
Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule. Fed Regist. 1998;63(91):26069-77.
(1998). Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule. Federal Register, 63(91), 26069-77.
Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor reporting--FDA. Direct Final Rule. Fed Regist. 1998 May 12;63(91):26069-77. PubMed PMID: 10179334.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule. PY - 1998/4/18/pubmed PY - 1998/4/18/medline PY - 1998/4/18/entrez SP - 26069 EP - 77 JF - Federal register JO - Fed Regist VL - 63 IS - 91 N2 - The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. 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 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 a significant adverse comment and withdraws this direct final rule. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10179334/Medical_device_reporting:_manufacturer_reporting_importer_reporting_user_facility_reporting_and_distributor_reporting__FDA__Direct_final_rule_ L2 - https://medlineplus.gov/medicaldevicesafety.html DB - PRIME DP - Unbound Medicine ER -