The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance to assist manufacturers in using an alternative process for getting low- to moderate-risk devices authorized through the third party 510(k) review program (3P510K). The guidance also describes the use of third-party review organizations for emergency use authorization (EUA) requests.
According to FDA, the guidance revises a draft version that was released for comment last year by clarifying the relationship between 510(k) review organizations and EUA third-party review organizations and clarifying conflicts of interest requirements for personnel of third-party review organizations. (RELATED: FDA updates third party 510(k) guidance, Regulatory Focus 21 December 2023)…
