FDA Proposes Program to More Efficiently Report Medical Device Malfunctions


Posted December 28, 2017

Medical device manufacturers may soon have a simpler and less time-consuming way to report device malfunctions to the Food and Drug Administration (FDA) using a proposed program developed to cut down on paperwork and improve transparency during postmarket surveillance.

In a Dec. 26 Federal Register notice, the FDA’s Center for Devices and Radiological Health (CDRH) announced the creation of a voluntary program intended to reduce the resources needed to create and review individual malfunction medical device reports (MDRs). Under the proposed Voluntary Malfunction Summary Reporting Program, manufacturers could submit MDRs for qualifying devices to the FDA in a more concise, summarized format on a quarterly basis.

The new program supports the FDA’s goal of streamlining malfunction reporting as outlined in the Medical Device User Fee Amendments Act of 2017. In many cases, the summary reports would take the place of individual reports, which often describe overlapping issues and add to the paperwork burden, according to the FDA.

"While manufacturers must report certain device malfunctions to the FDA, these individual reports often describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” said CDRH Director Jeffrey Shuren, in a statement. “We’re proposing to streamline this process through a summary reporting system that would enable us to more efficiently detect potential safety issues and free up agency resources to better focus on addressing them.”

Manufacturers would still be required to file individual reports when a death or serious injury occurs, Shuren noted.

The proposal follows a successful pilot program, begun in 2015, that demonstrated an 87% reduction in the volume of reports while “preserving the essential information regarding the context around malfunction events” in the summary MDRs, according to the Federal Register notice. The summary reports also proved to be more sharable and transparent, the FDA wrote.

The FDA described six principles that the summary reporting of malfunctions should follow:

  1. The FDA should have sufficient detail to understand the reportable malfunction events.
  2. The reporting should utilize a common format for the electronic reporting system used.
  3. The reported information should be transparent to the FDA and the public.
  4. Manufacturers should communicate information regarding an imminent hazard as soon as possible.
  5. Summaries do not change the regulatory requirements for MDR-related investigations or recordkeeping by manufacturers.
  6. Summary reporting information should not duplicate information received through other MDR reporting processes.

“For many manufacturers, this approach would greatly reduce the volume of reports that they would need to submit to FDA. For FDA, information would be received in a streamlined manner that would facilitate more efficient understanding of malfunction issues. For the public, summary reports could make malfunction event trends for a particular device more readily transparent,” the FDA said.

The list of device product codes eligible for the program has not been finalized, according to the agency, and may include devices from Class I, II, or III. Products are not intended to be eligible for the program until a product code has existed for at least two years.

The FDA is seeking comments on the proposed program until Feb. 26. Comments can be submitted online at www.regulations.gov.