FDA Pinpoints Devices for Reclassification From Class III to Class II

The FDA’s CDRH has pinpointed 21 medical device product codes as reclassification candidates, from Class III to Class II. The agency says it will rely more on postmarket data for affected products.

The FDA had previously announced a goal of reviewing 50 percent of all device product codes requiring Premarket Approval by December 2014. The agency has since said that it has gone beyond that goal, with CDRH reviewing 69 percent of all device product codes subject to PMA.

The move comes as the FDA hopes to make the premarket approval process more efficient and less costly for devicemakers, and is part of a larger comprehensive review of premarket and postmarket data collection processes. — Jason Scott