FDA Seeks To Boost Device Manufacturer Participation in Voluntary Malfunction Summary Reporting

Draft Guidance Is Intended To Help Device Firms Understand Option for Summary Submissions of MDRs
Dennis Tosh
December 14, 2022 at 05:34 PM EST
With the Dec. 8 posting of draft guidance on its Voluntary Malfunction Summary Reporting (VMSR) program for medical device manufacturers, the FDA hopes to help increase device company participation in the program, which is intended to ease companies’ reporting burden, help the agency use its resources more efficiently, and make reported device malfunction information more usef... Read More