FDA Needs To Improve Its Approval Process For Medical Device: Experts Say

A panel of medical industry experts at hearing on medical devices said to lawmakers that the Food and Drug Administration (FDA) needs to improve its approval process for medical devices, to ensure the safety, effectiveness and quality control. At congressional hearing on medical devices, Marcia Crosse of the Government Accountability Office presented shortcomings in both the pre and postmarket review of Class III medical devices such as pacemakers and replacement heart valves

Crosse point out that the FDA’s failure to review all class III devices through its most stringent premarket review process. Unless exempt by regulation, new devices must clear FDA premarket review through either the 510(k) premarket notification process. Crosse also mentioned the failure of the FDA to meet statutory requirements to inspect certain domestic establishments on a set schedule.