After announcing the implementation of minor technical changes to the instructions for the required malfunction summary reporting format in alignment with the current version of Form FDA 3500A, the U.S. Food and Drug Administration (FDA) has finalized its 2022 draft guidance document, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This resource outlines the principles of the VMSR program and product code eligibility, as well as the program's scope and instructions for summary reporting.
Medical device reports
Malfunction reports represent the majority of the more than two million medical device reports (MDRs) the FDA receives each year. Pursuant to 21 CFR § 803.19, the FDA may grant exemptions from and variations to manufacturer reporting requirements or may authorize changes to the frequency of reporting for the manufacturer. The VMSR program was implemented in 2018 to streamline malfunction reporting for devices with eligible product codes without compromising the FDA’s ability to monitor the safety of devices on the US market. The FDA further notes that malfunction summary reporting increases the transparency of malfunction event trends for the public.
US FDA Updates Rules on VMSR Manufacturer’s Program | Emergo by UL
US FDA Updates Rules on VMSR Manufacturer’s Program
The U.S. FDA has finalized its 2022 draft guidance document Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
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