ADVERSE EVENT GUIDANCE CHANGES FROM FDA (Orthopedics This Week)
The FDA recently issued a 54-page draft guidance to help device manufacturers figure out if an event is adverse and reportable. The draft addresses specific questions about reporting and record-keeping requirements for device-related adverse events.
You’ve got until October 7, 2013 to respond.
Adverse Event
According to the FDA, reportable events for manufacturers “are events that manufacturers become aware of that reasonably suggest 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.”
Recommendations
The FDA hasn’t updated its device reporting guidance in 16 years. The draft significantly expands on an earlier 1997 guidance for manufacturers and attempts to respond to concerns of industry. For example, it includes recommendations concerning:
Evaluating differences of medical opinion
Conducting follow-up investigations
Determining the expected life of the device
Reporting events for d...
