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.
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.
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