 
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
This draft guidance proposes recommendations to help manufacturers understand and use the VMSR program. The guidance, once finalized, is intended to further explain, but not change, the conditions of the VMSR program. The VMSR program reduces the number of individually reported device malfunction medical device reports (MDRs) that manufacturers must submit and allows the FDA to get a more efficient understanding of certain malfunction issues via a summary report.
The VMSR Program enables the FDA to efficiently detect potential safety signals and better use Agency resources to focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. For eligible device types, this voluntary program allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis. Reports from this voluntary program are publicly available in the MAUDE database. Importantly, reports of a death or serious injury are not allowed to be submitted via the VMSR Program and the FDA may still require individual malfunction reports—instead of summary reports—for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2022-D-2873 at www.regulations.gov by February 7, 2023 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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