FDA finalizes malfunction reporting requirement guidance for lower-risk devices to ease burdens

The US Food and Drug Administration (FDA) has finalized guidance on submitting voluntary malfunction summary reports for certain class I and class II lower-risk devices. The guidance is almost identical to the draft version but includes several report samples for manufacturers to reference.

On 28 August, FDA finalized a 2022 draft guidance on its Voluntary Malfunction Summary Reporting (VMSR) program that lays out conditions for manufacturers to submit quarterly malfunction reports in summary format instead of the usual individual malfunction reports that are required to be submitted every 30 days. The agency notes that the program allows stakeholders to identify medical device malfunction trends more easily and reduce the burdens of individual reporting requirements. (RELATED: Industry asks FDA to clarify voluntary malfunction reporting program requirements, Regulatory Focus 10 February 2023)

"This guidance describes and clarifies 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 medical device reports (MDRs) for device malfunctions in summary format under the program," said FDA. "Consistent with the goals outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter, the VMSR Program is intended to streamline reporting of device malfunctions."

FDA notes that it receives more than two million medical device reports (MDR) of potential deaths, serious injuries, and malfunctions every year, and malfunction reports represent the bulk of those reports.

The VMSR program began in 2018 and allows manufacturers of devices with eligible product codes to report summaries of certain malfunctions quarterly. Ultimately, the summary reports are meant to lessen manufacturers' administrative burdens without compromising patient safety while making it easier to see potential safety issues because of how the data is provided.

“For many manufacturers, we expect this approach will greatly reduce the volume of reports that the manufacturer needs to submit to FDA,” said FDA. “As more information is received in a streamlined manner, it can facilitate a more efficient understanding by FDA of malfunction issues.”

“For the public, summary reports may make malfunction event trends for a particular device more readily transparent,” the agency added. “We believe increased manufacturer participation in the program will enhance these benefits.”

Under the 2007 FDA Amendments Act (FDAAA), manufacturers of class I and most class II devices that are not permanently implantable, life-supporting, or life-sustaining are not required to submit individual MDR reports, though the agency may require individual MDR reports for certain class II devices that are in the interest of public health. These devices, instead, are allowed to be submitted every quarter in summary form as long as they must conform to certain principles laid out by the agency in the guidance.

For instance, the information in the summary reports should be detailed enough for the FDA to understand reportable malfunction events, increase efficiency, be transparent to regulators and the public, streamline the malfunction reporting process, and not duplicate other MDR reporting. A key principle is that manufacturers still need to let the FDA know of potential imminent hazards as soon as possible.

The guidance notes that when the VSMR program started in 2018, the agency evaluated all product codes for all device classes to determine which products were eligible. The agency decided that devices with product codes that have existed for less than two years are not eligible for the program unless they were created solely for administrative purposes since they did not have enough experience with the product.

"In FDA’s experience, this two-year period is important for having more timely, detailed information to monitor malfunction events," said FDA. "FDA continues to evaluate new product codes after they have been in existence for two years to determine whether it is appropriate for those product codes to be eligible for the VMSR Program. FDA also periodically evaluates ineligible product codes for eligibility changes."

While the draft version of the guidance includes an appendix with a hypothetical example of a product that qualifies for the VSMR program, the final guidance expands on the example by adding three sample report examples for manufacturers to refer to.

Final guidance

FDA finalizes malfunction reporting requirement guidance for lower-risk devices to ease burdens

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