FDA

FDA’s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs

By MedTech Intelligence Staff
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FDA

The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.

Today FDA announced it has finalized the Voluntary Malfunction Summary Program, the goal of which is to streamline the way in which malfunctions are reported while still giving the agency enough information to effectively monitor devices. Eligible manufacturers would only have to submit certain medical device reports (MDRs) related to device malfunctions in summary form on a quarterly basis (for certain product codes).

The program is in line with goals negotiated under MDUFA IV to streamline malfunction reporting.

“The FDA believes that grouping events that are the same or similar into a single summary report description will benefit manufacturers, the FDA, and the public. This approach is expected to reduce the number of reports manufacturers need to submit to FDA by approximately two thirds, and continue to provide sufficient detail to monitor the safety of devices on the U.S. market.” – FDA

FDA has identified the eligible product codes in its product classification database. Product codes must have been in existence for at least two years to be eligible. Manufacturers can use the same electronic submission form that is used to submit individual MDRs.

More information about the program is available on the Federal Register.

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