2024-19413. Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability  

  • 21 CFR part; guidance; or FDA form Topic OMB control No.
    803 Medical Device Reporting 0910-0437
    820 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910-0073
    806 Medical Devices; Reports of Corrections and Removals 0910-0359
    Form FDA 3500A MedWatch: Adverse Event and Product Experience Reporting System 0910-0291

Document Information

Published:
08/29/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2024-19413
Dates:
The announcement of the guidance is published in the Federal Register on August 29, 2024.
Pages:
70193-70195 (3 pages)
Docket Numbers:
Docket No. FDA-2022-D-2873
PDF File:
2024-19413.pdf