FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices.

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction.  The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report.  The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”

FDA began an initial VMSR pilot program in 2015.  Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter.  In that letter, FDA stated that it would “permit manufacturers . . . to report malfunctions on a quarterly basis and in a summary MDR format” for devices in certain product codes that the Agency would publish in a list.

In August 2018, FDA published a notice in the Federal Register granting an alternative under 21 C.F.R. § 803.19 permitting manufacturers of devices in eligible product codes to submit certain device malfunction MDRs in summary form on a quarterly basis (see our blog post on this notice here).

The draft guidance provides information about the VMSR Program eligibility and scope, reporting conditions, and the reporting process.

When FDA initially implemented the VMSR Program, in 2018, the Agency reviewed all product codes to determine eligibility for the program.  Product codes that had been in existence for less than two years were generally not eligible for the program, because FDA wanted more timely and detailed malfunction information from newer product codes.  The draft guidance states that FDA intends to periodically reassess product codes to update eligibility for the VMSR Program, but does not provide details on the frequency, timeline, or process for reassessment.

Each product code’s eligibility for the program is noted for that product code in FDA’s Product Classification database.  In assessing eligibility, FDA intends to consider the frequency of reported serious injuries and deaths, the number of 5-day reports (for events that require remedial action to prevent an unreasonable risk of substantial harm to the public health), and whether any devices in the product code have had any class I or class II recalls.  Manufacturers can also submit a request to FDA for a product code to be considered for eligibility in the VMSR Program.  The draft guidance sets forth a process for doing so.

As described in the draft guidance, there are certain conditions for participation in the VMSR Program.  Specifically, manufacturers that participate in the VMSR Program must submit individual reports, rather than summary reports, for (1) malfunctions associated with a 5-day report, (2) malfunctions that are the subject of certain device recalls, (3) when FDA has determined that individual MDR reporting is necessary to address a public health issue, (4) when FDA has determined that a manufacturer may no longer report in a summary reporting fashion (e.g., due to failure to comply with MDR reporting requirements), and (5) when a new type of reportable malfunction occurs for a device.

Summary malfunction reports should be submitted electronically on Form FDA 3500A.  The draft guidance provides instructions for completion of this form, including an appendix with a sample report.  Additionally, the draft guidance restates the VMSR reporting schedule set forth in the regulations:

In short, the guidance provides little detail beyond what was in the final rule and regulation.  But what it does provide may be of some practical use to manufacturers.  Interested parties can submit comments on the draft guidance to FDA until February 7, 2023 via Regulations.gov.