The Center for Devices and Radiological Health (CDRH) released a recent report that details how the agency believes their premarket approval (PMA) and 510(k) systems are performing after implementation of many actions. It has been nearly two years since the FDA announced a “Plan of Action” to update and improve the FDA’s premarket review of medical devices. The “Plan of Action” for premarket review includes 36 specific actions that were focused on increasing the predictability, consistency, transparency, efficiency, and timelines of device premarket reviews. Improvements not seen in decades were reported. The average time it takes to clear a 510(k), average time it takes to reach a decision on PMAs, and the percentage of submitted 510(k)s that are cleared and PMAs that are approved have all improved since the 2010 benchmark. The 24-page report can be found here. Need assistance with 510(k) or PMA devices? Contact Pearl at. firstname.lastname@example.org or call us at 317.899.9341.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.