Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification
This article was originally published in The Gray Sheet
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.