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USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program

Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released a draft guidance on the "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers" and "Content of Human Factors Information in Medical Device Marketing Submissions".

This draft guidance will help manufacturers understand and use the Voluntary Summary Malfunction Reporting (VMSR) Program, a voluntary program that allows manufacturers to report malfunctions related to devices with certain product codes to FDA in a summary form on a quarterly basis.

Among the benefits of this guidance is that it will increase transparency for the public, help FDA process certain malfunction reports more efficiently, enable both FDA and the public to identify malfunction trends more readily, and reduce manufacturer burdens.

In this draft guidance document, the FDA provides recommendations on how human factors information should be documented and included in marketing submissions for medical devices.

Using these recommendations, submissions for medical devices will be reviewed more efficiently and with more consistency.


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