FDA Announces Updated Guidance on 510K Processes

On December 20, 2023, the U.S. Food and Drug Administration (FDA) announced new draft guidance on the 510(k) Third Party Review (3P510k) Program and the Third Party Emergency Use Authorization (EUA) Review (3PEUA).

The draft guidance contains detailed steps regarding what is expected for submissions in both the 3P510k and 3PEUA programs. The former of these has been around since the Clinton Administration and is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. The latter is an outgrowth of the need to process so many EUA requests during the pandemic and was authorized by section 565 of the FD&C Act. The subsection that authorizes it was added as part of the PREVENT Pandemics Act of 2022 (section 2502 of the CAA, 2023).

The guidance (which includes helpful flowcharts) describes (1) what factors are considered when a device can be reviewed under the 3P510k program; (2) what the process is for recognition, suspension, or withdrawal of 3P510k review organizations under the program; (3) what is required for a successful review by the third party review organizations in both programs; (4) expectations of the Food and Drug Administration when dealing with conflicts of interest; and (5) the compensation process between the review organizations and other entities.

The full guidance is available here.