# Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
> **Food and Drug Administration** · Notification; order granting alternative. · Published 2018-08-17 · 83 FR 40973
## Document
- **Document number:** 2018-17770
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 40973
- **CFR reference:** 21 CFR 803
- **Publication date:** 2018-08-17
- **HHS docket:** Docket No. FDA-2017-N-6730
## Abstract

The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting 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." This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/08/17/2018-17770/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-program)
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