US FDA Updates Rules on VMSR Manufacturer’s Program

By Amelia Boldrick and Elizabeth Pugh

After announcing the implementation of minor technical changes to the instructions for the required malfunction summary reporting format in alignment with the current version of Form FDA 3500A, the U.S. Food and Drug Administration (FDA) has finalized its 2022 draft guidance document, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This resource outlines the principles of the VMSR program and product code eligibility, as well as the program's scope and instructions for summary reporting.

Medical device reports

Malfunction reports represent the majority of the more than two million medical device reports (MDRs) the FDA receives each year. Pursuant to 21 CFR § 803.19, the FDA may grant exemptions from and variations to manufacturer reporting requirements or may authorize changes to the frequency of reporting for the manufacturer. The VMSR program was implemented in 2018 to streamline malfunction reporting for devices with eligible product codes without compromising the FDA’s ability to monitor the safety of devices on the US market. The FDA further notes that malfunction summary reporting increases the transparency of malfunction event trends for the public.

VMSR program principles and eligibility

The guidance outlines the VMSR program principles, including the need for the collection of sufficient detail in summary reports to understand reportable malfunction events, as well as the requirement for reports to be provided in electronic format in a manner transparent to both the FDA and the public, regardless of whether events are reported individually or within a summary report. The VMSR program does not remove the manufacturer's obligation to communicate issues that pose a significant health risk as soon as possible, nor does it obviate the requirement for manufacturers to evaluate, review and investigate any complaint representing an MDR reportable event and maintain MDR event files.

Manufacturers of devices with eligible product codes need only begin providing malfunction MDRs quarterly and do not need to apply for participation in the program. If the manufacturer no longer wishes to participate, they may simply resume individual malfunction MDRs.

What is not part of the VMSR?

The VMSR program does not include events involving deaths and serious injuries or malfunctions associated with 5-day reports, including events requiring remedial action to prevent an unreasonable risk of substantial harm to public health or events for which the FDA requests submission of a 5-day report in writing.

What if the product code is ineligible for summary reporting?

Product codes generated less than two years prior are generally ineligible for summary reporting unless the product code was generated for administrative purposes only. The FDA periodically assesses and updates product codes for eligibility according to the device risk-benefit profile and available post-market safety information. Applicable changes are reflected in the FDA Product Classification Database. The guidance also provides instructions for manufacturers who wish to submit a request for eligibility consideration to the FDA.

Concluding remarks

In addition to increasing the efficiency of the FDA review process for certain malfunctions and the transparency of malfunction event trends for the public, summary reporting also presents manufacturers of eligible devices with an opportunity to reduce the administrative burden associated with submitting individual malfunction MDRs.

Post-market surveillance is an important facet of monitoring the safety and performance of a medical device once it is on the market. The VMSR increases the efficiency for both the FDA and manufacturers, while still publicizing these malfunction reports.