The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers. Written comments may be submitted by mail or electronically to the FDA within 90 days. When finalized, the guidance will supercede the 1997 guidance document with the same title. The draft guidance provides direction to medical device manufacturers regarding 5 day reports, 30 day reports and supplemental reports for adverse events.
The draft guidance also requires medical device manufacturers to:
- Submit reports of reportable events involving their medical devices to the FDA;
- Develop, implement and maintain written procedures for the identification and evaluation of medical device adverse events to determine whether the event is reportable; and
- Establish and maintain complete files for all complaints regarding medical device adverse events.
A medical device manufacturer is required to submit a report for an event that it “becomes aware” that “reasonably suggests” that a marketed device (i) may have caused or contributed to a death or serious injury, or (ii) has malfunctioned and the malfunction of the device or a similar device that it markets likely would cause or contribute to a death or serious injury if the malfunction recurs. Notably, manufacturers are deemed to “become aware” of an event when any employee becomes aware of information that reasonably suggests that an event is required to be reported or certain management employees become aware from information, including trend analysis, that an event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
Further, manufacturers must report device “user error”, regardless of whether the user error is the sole cause of the reportable event or only a contributing factor. According to the FDA guidance, user errors may reflect problems with device labeling, user interface, or other aspects of the device design.