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The FDA recently issued a 54-page draft guidance to help device manufacturers figure out if an event is adverse and reportable.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...
