Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations

What GAO Found The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) administers the Third Party Review Program, a voluntary alternative review process for selected low-to-moderate risk medical devices, such as diagnostic ultrasound systems and surgical lasers. Under this program, which is intended to facilitate faster reviews, device sponsors can contract with FDA-accredited entities. These entities, known as Third Party Review Organizations (third parties), conduct the initial review of certain premarket applications, known as 510(k) submissions.