The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting (VMSR) Program.

The VMSR program is an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis.

“This guidance describes and clarifies several aspects of the VMSR Program, including the FDA’s approach to determining the eligibility of product codes for the program and conditions for submitting medical device reports (MDRs) for device malfunctions in summary format under the program. Consistent with the goals outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter,(1) the VMSR Program is intended to streamline reporting of device malfunctions,” the introduction the draft guidance reads.

The medical device reports program is a postmarket surveillance tool the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments.(2)

FDA says the VMSR Program is intended to yield benefits for both FDA and the public, such as increasing transparency for the public, helping FDA to process certain malfunction reports efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers, the administration says.  This guidance is intended to explain, but not change, the conditions of the VMSR Program.


  1. Available at