FDA finalizes Voluntary Malfunction Summary Reporting Program to streamline malfunction reporting for certain devices

FDA finalizes Voluntary Malfunction Summary Reporting Program to streamline malfunction reporting for certain devices

The FDA has finalized the Voluntary Malfunction Summary Reporting Program, which allows eligible manufacturers to report certain device malfunction medical device reports (MDRs) on a quarterly basis and in summary form for certain product codes. The goal of the program is to provide an efficient, streamlined approach to report malfunctions while maintaining sufficient detail for the FDA to monitor devices effectively. 

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. 

The Voluntary Malfunction Summary Reporting Program allows manufacturers to use the same electronic submission form (FDA Form 3500A) that they use to submit individual MDRs.  This streamlines the process and eliminates the need to develop a new reporting system. The Voluntary Malfunction Summary Reporting Program may make it easier for the public to find and understand related events because similar malfunctions will be grouped in summary reports, which will be posted in the FDA’s Manufacturer and User Facility Device Experience (MAUDE)database. 

Eligible product codes, including product codes for device-led combination products, are identified in the FDA’s Product Classification Database. Only product codes that have existed for at least two years are potentially eligible for the Voluntary Malfunction Summary Reporting Program. The FDA will periodically evaluate new product codes after they have been in existence for at least two years. This information will be used to determine whether the product codes should be eligible for the program.

The Voluntary Malfunction Summary Reporting Program reflects goals for streamlining malfunction reporting that were negotiated under the MDUFA IV agreements. More information about the program is available in the Federal Register notice.

Center for Devices and Radiological Health
U.S. Food and Drug Administration