Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

9 December 2022 – the FDA published draft guidance on the VMSR program for industry and FDA staff. Submit comments by 7 February 2023.

FDA is issuing this draft guidance to help manufacturers better understand and use the Voluntary Summary Malfunction Reporting (VMSR) Program. This guidance clarifies FDA’s approach for determining the conditions for submitting medical device reports (MDRs) and permits manufacturers of devices in eligible product codes to report certain device malfunctions in summary form on a quarterly basis.