The FDA recently issued a guidance document for its Voluntary Malfunction Summary Reporting (VMSR) Program, designed to streamline the process of reporting medical device malfunctions. This program, initiated in 2018, allows manufacturers to submit quarterly summary reports for certain low-risk device malfunctions instead of filing individual reports for each event. This shift reduces the administrative burden on both manufacturers and the FDA, while maintaining the integrity of device safety monitoring.

The new guidance, finalized in August 2024, provides further clarification on key aspects of the VMSR program, including how manufacturers must submit separate summary reports for each unique combination of device model, brand name, and fault codes. These reports are publicly accessible via the FDA’s MAUDE database and are meant to offer a comprehensive overview of all reportable malfunctions. However, in cases involving fatalities or serious injuries, manufacturers are still required to submit individual reports, adhering to the conditions outlined in CFR Part 803.

The FDA's updated guidance stresses the importance of ensuring that summary reports contain detailed information comparable to individual reports to properly address malfunction trends. The guidance also specifies that manufacturers whose product codes do not qualify for the VMSR program must continue to file individual malfunction reports in line with standard regulatory requirements.

In situations where summary reports are not submitted as per the established guidelines, or where a device is recalled, individual malfunction reports are mandated. Additionally, manufacturers failing to meet VMSR requirements must revert to individual reporting unless an exemption is granted.

These updates aim to enhance both the efficiency and transparency of the malfunction reporting process while ensuring critical safety data is readily available to the public and regulators alike.

 

 

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