The FDA receives more than 2 million medical device reports (MDRs) annually related to deaths, serious injuries, and malfunctions of medica devices. Especially malfunction reports represent most of the MDRs received each year.
On August 28, 2024, the FDA announced final guidance for the Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. The VMSR program simplifies the reporting of device malfunctions and has been in place since 2018, allowing manufacturers to submit summary reports to the FDA on specific malfunctions related to medical devices with certain product codes on a quarterly basis.
A brief overview of the VMSR Program is as follows:
1. Eligibility
- The VMSR Program allows manufacturers of medical devices to submit summary reports for malfunction incidents reported through the program, based on specific product codes.
- The eligibility of specific product codes is determined by the FDA based on whether sufficient data can be provided to assess the safety related to the performance of the product and detect potential risk. If a specific product code is deemed eligible, the FDA plans to appropriately update the product classification database.
2. Scope
- The VMSR Program does not include all event types and is limited to certain malfunction incidents. Events that result in or have the potential to result in serious injury or death cannot be reported through the VMSR Program and require individual MDR submissions.
3. Event Types and Reporters Not Covered by the VMSR Program
- Reportable deaths and serious injuries.
- Malfunctions related to the 5-day report required under 21 CFR 803.53
- Importers and medical device user facilities.
Please refer to attached document below for more information
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