Docket Number: FDA-2022-D-2873 Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
FDA is issuing this 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.
Submit Comments
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:
Dockets Management
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.
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Content current as of:
12/09/2022
