FDA finalizes Voluntary Malfunction Summary Reporting guidance

Dive Brief:

The Food and Drug Administration finalized guidance on Thursday for its Voluntary Malfunction Summary Reporting (VMSR) program for medical device manufacturers.
The program, launched in 2018, now allows participating companies to submit certain device malfunction reports in summary form on a quarterly basis instead of individual reports every 30 days.
The final guidance is mostly unchanged from the draft version the FDA published in 2022. The changes detail how the FDA determines product eligibility for inclusion in the program.

Dive Insight:

Most of the more than 2 million medical device reports received by the FDA each year relate to malfunctions. The FDA believes moving to quarterly summaries of some of those reports will boost its capacity to monitor devices and reduce the burden on manufacturers.

Manufacturers choose to participate in the program by submitting summary reports for eligible product codes and do not need to send a separate application to FDA to join. The final guidance details product code eligibility, individual reporting conditions and summary reporting instructions. It also features some changes in response to feedback on the draft.

Medtech trade group Advamed said “clear and consistent eligibility criteria will encourage understanding and increased utility of the program” in its feedback on the draft. Advamed asked the FDA to provide a list of codes eligible for VMSR reporting on its website. The Medical Device Manufacturers Association sought clarification on the requirements for using Form 3500A for reporting adverse events or product problems.

Advamed also asked the FDA to clarify when a manufacturer may choose to opt out of the program. The final guidance features a new line stating that, because the program is voluntary, companies may choose to leave the program and resume submitting individual 30-day malfunction reports at any time.

The FDA also added three sample reports to an appendix to the guidance. The reports have sections that describe the event or problem, state the number of events summarized and allow the manufacturer to provide additional “narrative.” The narrative sections convey steps a manufacturer took to solve a problem, such as giving facilities instructions on how to tighten screws that hold bed rails in place.