FDA MDR hub highlights VMSR guidance and quarterly malfunction reporting

FDA’s “Medical Device Reporting (MDR): How to Report Medical Device Problems” page (published March 27, 2025) includes an “Update August 28, 2024” stating that FDA issued the final guidance on the Voluntary Malfunction Summary Reporting (VMSR) Program and directing readers to the VMSR program page for updated information.

For device vigilance and regulatory compliance teams, the practical signal is not a new enforcement action or a product-specific change, but rather FDA’s continued use of its MDR reporting hub to steer manufacturers toward the finalized VMSR guidance and the current VMSR program information page. This can matter operationally because MDR process documentation and training often rely on “hub” pages as authoritative starting points for staff performing malfunction triage and reporting decisions.

The FDA VMSR program page states that the program began in 2018 and permits manufacturers to report certain device malfunction MDRs in summary form on a quarterly basis. It also states that FDA issued VMSR guidance describing and clarifying aspects of the program, including FDA’s approach to determining eligibility of product codes and the conditions for submitting malfunction MDRs in summary format.

Because the excerpts provided do not list specific eligible product codes or the detailed conditions/criteria, teams should treat FDA’s links (the MDR hub page, the VMSR program page, and the final VMSR guidance) as the authoritative sources for operational detail.

Based on FDA’s framing, device manufacturers that submit malfunction MDRs and may use VMSR for eligible product codes are the most directly exposed to the compliance risk of outdated internal references. Even where an organization does not use VMSR, staff may encounter VMSR references when using FDA’s MDR hub as a reporting resource.

Operational areas to validate include MDR decision trees and malfunction triage workflows (to distinguish when individual malfunction MDRs are expected versus when quarterly summary reporting may be used), eligibility verification steps (so staff know where to verify product-code eligibility and applicable conditions as described by FDA), controlled document governance (ensuring SOPs and training reference the current FDA page titles and URLs), and safety/complaint system support (documenting that outputs and queues can support individual MDR submissions or quarterly summary-format reporting where applicable).

FDA’s MDR hub update specifically calls out the final VMSR guidance and provides a direct path to updated VMSR program information. For teams operating under US MDR requirements, that combination can serve as an informal operational baseline that FDA expects manufacturers to be able to navigate and apply correctly. A short alignment check during the next document governance cycle (or sooner if VMSR is actively used) may reduce the risk of re-triage, reporting corrections, or audit/inspection observations tied to MDR process governance.

Device vigilance teams should confirm whether VMSR is used (or could be used) for any applicable product codes and ensure internal SOPs, decision trees, and training accurately reflect FDA’s current MDR/VMSR framing and links, with system support documented accordingly.