FDA Issues Plan for “Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews” and Draft Guidance for 510(k) Third Party Review Program

FDA Issues Plan for “Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews” and Draft Guidance for 510(k) Third Party Review Program

Today, the FDA issued a plan for "Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews." As a critical component of this plan, FDA concurrently issued a draft guidance document entitled “510(k) Third Party Review Program.”

The plan to eliminate FDA re-review of 510(k)s provides information to ensure that third parties are equipped to perform an FDA-equivalent review. The plan describes a comprehensive framework for FDA processing of third party 510(k) submission packages and the plan further outlines the implementation of program monitoring activities authorized under FDA Reauthorization Act of 2017 (FDARA) to strengthen the program.

When final, the “510(k) Third Party Review Program” guidance will represent FDA’s current thinking regarding the Third Party Review Program, including factors used to determine device type eligibility, the process for recognition of third party review organizations, and commitments authorized under FDARA to strengthen the program.

The 510(k) Third Party Review Program provides manufacturers an alternative process for premarket review of certain low-to-moderate risk medical devices. This pathway may yield faster 510(k) decisions by having FDA recognized third party review organizations complete an FDA-equivalent review and provide recommendations. 

The draft guidance replaces the 2016 draft guidance entitled "510(k) Third Party Review Program" and reflects statutory changes made by the FDARA. 

We welcome your comments and suggestions regarding the draft guidance and plan to eliminate FDA re-review of 510(k). The comment period will be open for 90 days in the Federal Register under docket number FDA-2016-D-2565.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health