Data / Federal rules / 2024-19414
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
The Food and Drug Administration published this final rule in the Federal Register on August 29, 2024.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program."
Key facts
- Document number
- 2024-19414
- Type
- Final rule
- Action
- Notification; order granting modification to alternative
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 29, 2024
- Dates
- This modification applies to voluntary summary reports for reportable malfunction events that manufacturers become aware of on or after August 29, 2024.
- Docket
- Docket No. FDA-2017-N-6730
- Code of Federal Regulations
- 21 CFR 803
- Pages
- 5
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Published in August 2024
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.