FDA Issues Final Guidance on the 510(k) Third Party Review Program

Today, the U.S. Food and Drug Administration (FDA) issued final guidance: 510(k) Third Party Review Program. In addition, the FDA is updating the list of devices eligible for review under the 510(k) Third Party Review Program. Through these actions, the FDA has enhanced and strengthened the 510(k) Third Party Review Program for the benefit of the patient while the standard for FDA’s medical device review has been maintained.

Read the Guidance

The final guidance:

Describes the factors the FDA uses to determine device type eligibility for review by Third Party Review Organizations (3P510k Review Organizations);
Outlines the FDA’s process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations; and
Ensures consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA to eliminate the need for routine, substantive re-review by the FDA.

Key features of the 510(k) Third Party Review Program:

Clarifies expectations for 3P510k Review Organizations of how to meet the FDA’s standard for 510(k) eligible product review, which in turn is intended to eliminate the need for routine, duplicative re-reviews of certain information by FDA staff. The Third Party Review Program is intended to support CDRH’s mission to protect and promote public health by enabling FDA to focus its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by 3P510k Review Organizations.
Greater utilization of the voluntary Third Party Program allows the FDA to expedite patient access to certain low-to-moderate risk and less complex devices, without changing our statutory or data requirements, by reducing agency review times to 30 days or less.
Provides manufacturers an efficient, consistent and predictable process to request review of 510(k) submissions by accredited, FDA recognized organizations; and
Leverages high quality, FDA-equivalent reviews for low-to-moderate risk and less complex devices to improve the FDA’s overall productivity and enable us to focus more of our time and resources on evaluating applications for more complex devices.

Upcoming webinar on this final guidance

On April 16, 2020, the FDA will host a webinar for manufacturers, 3P510k Review Organizations, and others interested in learning more about this final guidance.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.