# Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
> **Food and Drug Administration** · Notification; order granting modification to alternative. · Published 2024-08-29 · 89 FR 70096
## Document
- **Document number:** 2024-19414
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 70096
- **CFR reference:** 21 CFR 803
- **Publication date:** 2024-08-29
- **HHS docket:** Docket No. FDA-2017-N-6730
## Abstract

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."

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/08/29/2024-19414/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-for)
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