Tags

Type your tag names separated by a space and hit enter

Medical devices; humanitarian use of devices--FDA. Direct final rule.
Fed Regist. 1998 Apr 17; 63(74):19185-90.FR

Abstract

The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These 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). 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 ApprovalEmergency TreatmentEquipment SafetyHumansResearch DesignRisk-TakingUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10178430

Citation

"Medical Devices; Humanitarian Use of devices--FDA. Direct Final Rule." Federal Register, vol. 63, no. 74, 1998, pp. 19185-90.
Medical devices; humanitarian use of devices--FDA. Direct final rule. Fed Regist. 1998;63(74):19185-90.
(1998). Medical devices; humanitarian use of devices--FDA. Direct final rule. Federal Register, 63(74), 19185-90.
Medical Devices; Humanitarian Use of devices--FDA. Direct Final Rule. Fed Regist. 1998 Apr 17;63(74):19185-90. PubMed PMID: 10178430.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Medical devices; humanitarian use of devices--FDA. Direct final rule. PY - 1998/3/24/pubmed PY - 1998/3/24/medline PY - 1998/3/24/entrez SP - 19185 EP - 90 JF - Federal register JO - Fed Regist VL - 63 IS - 74 N2 - The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These 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). 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/10178430/Medical_devices DB - PRIME DP - Unbound Medicine ER -