Draft Guide on 510(k) Third-Party Review Program

Federal Register notice: FDA has made available a draft guidance entitled “510(k) Third-Party Review Program.” The document reflects amendments made to the third-party review program by the FDA Reauthorization Act of 2017, which directed the agency to issue draft guidance on the factors that will be used in determining whether a Class 1 or Class 2 device type, or subset of such device types, is eligible for review by an accredited person. The guidance is intended to (1) describe factors FDA will use in determining device type eligibility for review by third-party reviewer organizations; (2) outline the agency’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for third-party reviewer organizations; and (3) ensure consistent quality of work among third-party reviewer organizations through the MDUFA 4 commitments authorized under the FDA Reauthorization Act. To view the notice, click here.