Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page. The update includes information on how to determine whether a device product code is eligible for summary reporting; the types of devices, manufacturers, and reportable device malfunctions that are not eligible for the VMSRP; and how to submit eligibility requests. Although there is little new information on the parameters of the VMSRP, the update emphasizes FDA’s intent to exclude from the program specific manufacturers who have failed to comply with applicable MDR requirements or to follow the conditions of the program.

In August 2018, FDA launched the VMSRP, which allows participating companies to submit certain medical device malfunction reports (not serious injury or death event reports) in summary form on a quarterly basis, as opposed to filing individual MDR reports, as we explained here. Now, FDA has provided clarification that devices, manufacturers, and specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations:

1. For certain reportable malfunctions:

   1. Malfunctions associated with a 5-day report under 21 CFR § 803.53(a).

   2. Malfunctions that are the subject of a device recall, until the recall is terminated.

   3. Malfunctions that are of a new and previously unreported type for that particular device.

2. When FDA determines that individual reporting is necessary to address a public health issue, such as:

   1. Where the device is reusable and represents a high risk of infection if not adequately reprocessed. Appendix E of the FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” identifies device types associated with such risks.

   2. Where there is a high level of uncertainty regarding device risk.

   3. Where malfunction events are potentially attributable to complex failure modes and root causes are not well understood.

   4. Where there are ongoing signals or other safety-related investigations for the device.

3. If FDA determines that a specific manufacturer is no longer allowed to participate in the program. Examples of situations where this may occur include:

   1. Where there has been a failure to comply with applicable MDR requirements or a failure to follow the conditions of the VMSR program.

   2. Where there is a need to monitor a public health issue, such as a safety-related investigation involving the specific manufacturer.

In addition, as stated in the 2018 Federal Register notice, FDA does not intend to consider devices under product codes in existence for fewer than two years to be eligible for the program, unless the new product code was issued solely for administrative reasons. Manufacturers can use FDA’s online Product Classification Database to determine which product codes are currently eligible for summary reporting under the VMSRP. Requests for FDA to consider the addition of currently ineligible products codes to the VMSRP can be emailed to MDRPolicy@fda.hhs.gov, along with 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; and

• A complete statement of the request and rationale for the request, including actions taken to address any issues noted in prior FDA correspondence regarding device eligibility, if any.

Copies of any prior correspondence with FDA regarding device eligibility status should be included as well.

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