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Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification

CDRH says it exceeded its goal to retrospectively review half of all pre-2010 PMA device types. So far, 21 categories have been slated as candidates for downclassification and another 21 may be tagged for shifting some data requirements to the postmarket.

FDA’s device center has proposed premarket data shortcuts for 21 PMA device types ranging from silicone breast implants to catheter ablation systems to more than a dozen in vitro diagnostic systems in one fell swoop. At the same time, CDRH has identified another 21 PMA categories that might be able to be downclassified from class III to class II.

This comes into response to a pledge the center made in early 2014 as part of an overall priority to “strike the right balance” between premarket and postmarket data collection. Specifically, CDRH said it would retrospectively review half of all PMA device types approved prior to 2010 by the end of 2014 to determine when it would be appropriate to shift some pre-market data requirements to the post-market, or to down-classify certain product categories

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