Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers Draft Guidance for Industry and Food and Drug Administration Staff December 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
FDA is issuing this draft guidance to help manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting (VMSR) Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis. FDA’s VMSR Program is intended to yield benefits for both FDA and the public, such as increasing transparency for the public, helping FDA to process certain malfunction reports efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers. This guidance is intended to explain, but not change, the conditions of the VMSR Program.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-2873.