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Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Jan 13, 2023 | News

Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary...

Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

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Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

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