When Is It Best to File an MDR?

One of the issues AdvaMed and FDA have been discussing as part of FDA's Postmarket Transformation Initiative is the question of when is the best time to file complex Medical Device Reports, said AdvaMed's Jeff Secunda at an AdvaMed media briefing on postmarket issues today. If an incident with a complex device occurs, only sketchy information will be available at first, he said. Should firms stick with rules that require them to report information immediately, even if it's incomplete, or should they be allowed longer time for MDR preparation?"You must [file MDRs] immediately, but it might be more effective to report more complete information and open up the reporting timeframe if the product requires extensive analysis," he said. "We want to identify those that might benefit from longer reporting timeframes."That, he said, is the "most interesting and challenging" issue on the postmarket-discussion table right now.