FDA Finalizes Guidance on 510(k) Third Party Review Program

The FDA has released final guidance detailing how it approves third-party review organizations and which devices are eligible for their evaluations.

The third-party review program designates organizations that meet certain criteria to conduct assessments of low-to-moderate risk and less complex devices, with the aim of giving devicemakers an alternative that may speed up the clearance process and enable the FDA to focus on more complicated, higher-risk devices.

Third-party review organizations must be independent of the FDA and any manufacturers, vendors or suppliers. They “shall not engage in the design, manufacture, promotion, or sale of devices” and must be impartial in their decisions, the agency said.