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. These third party reviews occur prior to agency officials making the final decision about whether the devic.
Reported by Claire WalshMedical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations.
The item is dated Mon, 21 Sep 2026 07:11:57 -0400.
TeamCog is carrying it as a audits report from GAO reports and testimonies RSS.
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.
These third party reviews occur prior to agency officials making the final decision about whether the devic…
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GAO reports and testimonies RSS. Accessed 2026-09-21T15:00:07.485Z.