AAMI News February 2018

FDA Seeks to Change Reporting of Medical Device Malfunctions

FDAMedical device manufacturers may soon have a simpler and less time-consuming way to report device malfunctions to the Food and Drug Administration (FDA) by participating in a voluntary program intended to cut down on paperwork and improve transparency during postmarket surveillance.

Under the proposed Voluntary Malfunction Summary Reporting Program, manufacturers could submit malfunction medical device reports (MDRs) for qualifying devices to the FDA in a more concise, summarized format on a quarterly basis. 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.

“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 agency wrote.

Manufacturers would still be required to file individual reports in the event of a death or serious injury.

The FDA described six principles required for the summary reporting of malfunctions:

  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.

The list of device product codes eligible for the program has not been finalized, according to the FDA, but it may include devices from Class I, II, or III, a classification system which pertains to device risk. 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.