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89 FR (08/29/2024) » 2024-19413. Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
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