In August 2024, the FDA announced the release of final guidance titled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.” The purpose of this guidance is to provide device manufacturers with an enhanced understanding of the VMSR program as it describes several aspects of the program, including the FDA's approach to determining the eligibility of product codes and the conditions for submitting medical device reports (MDRs) for device malfunctions. Each year, the FDA receives over two million reports of suspected device-related deaths, serious injuries, and malfunctions, with malfunctions representing the majority of such reports.
The VMSR is an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to the FDA in a summary format on a quarterly basis as a substitute for individual reports. This program provides increased transparency to consumers, allows for improved efficiency for the FDA in processing malfunction reports, and serves to reduce the burden on manufacturers. It’s important to highlight that only certain product codes are eligible for VMSR, yet the FDA plans to continually evaluate additional codes for potential inclusion in the program. Generally, product codes in existence less than two years are ineligible. A link to the FDA’s product classification database is provided here where stakeholders can confirm whether a device is eligible or not for summary reporting.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
With respect to the VMSR program, the FDA has identified these six overarching principles:
- The collection of information in summary format should allow FDA to collect sufficient detail to understand reportable malfunction events;
- To increase efficiency, summary malfunction reporting should occur in a common format for the electronic reporting system used;
- Information about reportable malfunctions should be transparent to FDA and to thepublic, regardless of whether the information is reported as an individual MDR or a summary report. Information contained in a summary malfunction report that is protected from public disclosure under applicable disclosure laws is redacted prior to release of the report;
- Manufacturers should communicate information regarding an imminent hazard at the earliest time possible;
- Summary reporting is meant to streamline the process of reporting malfunctions. It does not change regulatory requirements for MDR-related investigations or record keeping by manufacturers. For example, manufacturers participating in the VMSR program remain subject to requirements for establishing and maintaining MDR event files under 21 CFR 803.18. In addition, under the Quality System regulation, manufacturers must evaluate, review, and investigate any complaint that represents an MDR reportable event; and
- Summary reporting information should not be duplicative of information received through other MDR reporting processes.
Manufacturers may “self-elect” to participate in the VMSR program by submitting summary malfunction reports for eligible product codes. As participation in the VMSR program is voluntary, applicants may exit the program at any time. Further, companies may submit requests to the FDA for specific product codes to be considered for eligibility in the program by emailing the FDA at MDRPolicy@fda.hhs.gov. Such requests to the FDA should include, at a minimum, the following information:
- The firm’s name, address, registration number;
- The contact person’s name, telephone number, and email address;
- Complete device identification and description, including product code and review panel;
- A complete statement of the request and justification for the request, including a discussion of known information related to the product code’s benefit-risk profile and postmarket safety, and why individual malfunction reporting is not necessary; and
- As part of the justification for the request, a manufacturer should provide a copy of any prior FDA correspondence (including the references to the Document ID #) regarding device eligibility status and describe any actions taken to address any issues noted in prior FDA correspondence regarding device eligibility for participation in the VMSR Program.
If you would like additional guidance regarding the VMSR program, or should you need any assistance with regulatory compliance or quality assurance matters for your devices, please contact us at PRP.
