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  5. Voluntary Malfunction Summary Reporting Program
  1. Medical Device Reporting (MDR): How to Report Medical Device Problems

Voluntary Malfunction Summary Reporting Program

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Background

The Voluntary Malfunction Summary Reporting (VMSR) program began in 2018 and permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. It reflects a pilot program conducted in response to changes made by Section 227 of the Food and Drug Administration Amendments Act of 2007 and the goals for streamlining malfunction reporting outlined in the commitment letter agreed to by the FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The FDA believes the program will enhance the FDA's capacity to effectively monitor many devices.

In the Federal Register of December 26, 2017 (82 FR 60922), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit reporting by a manufacturer of certain device malfunctions in summary form on a quarterly basis, subject to certain conditions, and requested comments from the public. On August 17, 2018, (83 FR 40973) the FDA issued a notification granting this alternative and describing the overarching principles for the VMSR program. On August 29, 2024, the FDA issued a notification announcing a minor, technical modification to the VMSR program (89 FR 70096) to align with the current Form FDA 3500A and current MDR adverse event codes. Key among these principles is transparency of this information to the FDA and to the public, regardless of whether the information is reported as an individual MDR or VMSR.

On August 29, 2024, the FDA issued the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers guidance document to describe and clarify several aspects of the VMSR Program, including the FDA’s approach to determining the eligibility of product codes for the program and the conditions for submitting MDRs for device malfunctions in summary format under the program. This guidance is consistent with the modification notice (89 FR 70096).

Under the VMSR program, manufacturers submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions, and the summary reports are available to the public in MAUDE. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

Eligibility Information

The FDA regularly assesses the eligibility of product codes for the VMSR program.

Search Eligibility in the Products Classification Database

Comprehensive List of Eligible Product Codes

Changes in Product Code Eligibility to Participate in the Voluntary Malfunction Summary Reporting (VMSR) Program

Manufacturers of devices in the referenced product code(s) may submit summary reports of reportable malfunction events for those devices in accordance with the conditions described in the August 17, 2018 Federal Register notice (83 FR 40973) and republished in the August 29, 2024 FR Notice (89 FR 70096), which announced a minor, technical modification to the VMSR program. Information regarding the product codes eligibility for participating in the VMSR Program is made available in the FDA Product Classification Database.

It is your firm’s responsibility to take the steps necessary to ensure compliance with the applicable laws and regulations administered by the FDA and the conditions of the VMSR Program. If a manufacturer does not submit summary reports for reportable malfunction events in accordance with the conditions described in the FR notices (83 FR 40973 and 89 FR 70096), including the reporting schedule and format, then the manufacturer must submit individual malfunction reports in compliance with all requirements under CFR Part 803, unless the manufacturer has been granted a different exemption, variance, or alternative that applies. Additional information regarding the VMSR Program can be found in the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers guidance.

Please note that manufacturers of devices of product codes ineligible to participate in the VMSR Program must submit individual reports that comply with all applicable requirements of 21 CFR part 803 for reportable malfunction events.

If a manufacturer would like to request under § 803.19(b) that CDRH add an ineligible product code to the list of eligible product codes for the VMSR Program, it can send a request to the MDRPolicy@fda.hhs.gov mailbox. Refer to the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers guidance document for information about what to include in the eligibility change request.

Questions About the Voluntary Malfunction Summary Reporting (VMSR) Program

If you have any questions regarding the VMSR Program, you may contact the MDR Team HelpDesk by electronic mail at MDRPolicy@fda.hhs.gov.

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