The FDA recently issued a lengthy draft guidance titled “Medical Device Reporting for Manufacturers.” Similar to the related regulations, found at 21 C.F.R. § 803, the draft guidance discusses the requirements for reporting adverse events related to medical devices in a question and answer format. The draft guidance even converts the definitions of 21 C.F.R. § 803.3, which are crucial to understanding the reporting obligations, into a question and answer format. Thus, much of the draft guidance will be familiar to those who deal with the existing regulations on a regular basis.

For example, the draft guidance identifies the following basic requirements of manufacturers with respect to device reporting:

  • To submit to FDA reports of MDR reportable events involving their medical devices
  • To develop, maintain, and implement written procedures for the identification and evaluation of all adverse medical device events to determine whether the event is an MDR reportable event; and,
  • To establish and maintain complete files for all complaints concerning adverse medical device events.

In this connection, the draft guidance summarizes the definition of a reportable event as an event that “manufacturers become aware of that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

The second half of the draft guidance, which addresses what to do in specific situations and specific questions about completing FDA Form 3500A in connection with a report, is likely to be of more interest to those already familiar with the regulations. Some of the issues addressed in this part of the draft guidance include:

  • Whether a delay in surgery related to a device is a reportable event
  • How to determine the expected life of a device
  • Whether events already mentioned in the labeling are reportable
  • Whether an event indirectly caused by a failed diagnostic device is reportable
  • Whether an event is reportable when there is a conflict in medical opinion as to whether the device contributed to the event
  • How to report adverse events involving the same patient and device but occurring on different days
  • The amount of effort required for a follow-up investigation
  • Whether an event is reportable if the device is being used under an IDE
  • The reportability of events occurring outside the U.S.
  • Whether a manufacturer has an obligation to submit a report when it has ceased marketing the device
  • Whether a manufacturer must investigate and submit a report on an event it becomes aware of through literature

A copy of the draft guidance can be found here.