AdvaMed and FDA Review Timing of Complex MDRs

NEWS TRENDS

FDA's current position is that MDRs must be filed as soon as possible after a firm becomes aware of a serious incident. That may change as a result of dialogue with AdvaMed.

AdvaMed and FDA have been discussing a number of topics as part of FDA's Postmarket Transformation Initiative. The “most interesting and challenging” issue on the postmarket-discussion table right now is the best time to file complex MDRs, said AdvaMed's Jeff Secunda. Secunda, the organization's associate vice president for technology and regulatory affairs, spoke at an AdvaMed media briefing on postmarket issues in April.

If an incident with a complex device occurs, only partial 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 time frame if the product requires extensive analysis,” he said. “We want to identify those that might benefit from longer reporting time frames.”

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