September 13, 2018
“The FDA continues to take steps to encourage advances in medical devices. We’re working to modernize the organization and structure of our review processes to make sure that we’re helping to efficiently advance beneficial new innovations,” said FDA Commissioner Scott Gottlieb, M.D. “As part of our efforts to expedite patient access to certain lower-risk devices, we’re taking new steps to better leverage reviews provided by experts in FDA-recognized third party review organizations. These third-party reviews must be equivalent in rigor and completeness to the kinds of reviews that we’d conduct. Today we’re issuing a comprehensive plan to advance this opportunity by streamlining our own FDA review of medical device premarket submissions that have already undergone a review by qualified, expert third parties. For eligible submissions, the FDA will review the expert recommendations of the third party to make its final decision and generally will not re-review the submission itself. Leveraging high quality, FDA-equivalent outside reviews for lower-risk products can improve the FDA’s overall productivity and enable the agency to focus more of its time and resources on evaluating applications for higher-risk and more complex devices. Today we’re also issuing draft guidance that provides a comprehensive outline of the FDA’s approach to improving the third-party review program for certain medical devices. The guidance, once final, is intended to provide clarity and transparency for industry and FDA-recognized third-party review organizations. The goal is to make the evaluation of certain lower-risk medical devices more efficient, while maintaining the FDA’s gold standard for product review. The draft guidance outlines factors used to determine which device types are most appropriate for the program, the process the agency would follow when deciding whether to recognize third party review organizations, and specific commitments Congress authorized to strengthen the program. While the framework outlined today seeks to improve the efficiency of the review of 510(k) submissions for certain well-understood, lower-risk devices, the final authority to decide which devices may proceed to market remains with the FDA. We will ensure that third-party reviews use the same standard of evaluation that the agency does and meet our high standards. Today’s framework demonstrates the FDA’s continued commitment to ensuring a robust, rigorous, and streamlined third-party review process to advance timely patient access to safe, effective, and high-quality medical devices.”
The comprehensive plan issued today, “Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews,” addresses common reasons for FDA re-review of 510(k) applications that have undergone an initial review by qualified third parties. The goal of the new policy is to help advance more opportunities for the FDA to rely on reviews conducted by third parties that are equipped to perform an FDA-equivalent review. The plan outlines how FDA will implement monitoring activities authorized under the FDA Reauthorization Act of 2017 (FDARA) that are aimed at strengthening the FDA’s Third Party Review Program.
This plan and the draft guidance issued today, “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” are part of the agency’s ongoing efforts to improve the efficiency and consistency of the premarket notification (510(k)) review process. The 510(k) Third Party Review Program provides manufacturers a streamlined process to request review of 510(k) applications by accredited, FDA-recognized organizations. The draft guidance outlines factors to determine the low-to-moderate risk device types that are most appropriate for the program, based on the expanded eligibility criteria set forth in FDARA. Because much of the review will be conducted by outside experts, the program is expected to reduce agency review times to 30 days or less by eliminating duplicative re-reviews of certain information by FDA staff. The draft guidance replaces the 2016 draft guidance titled "510(k) Third Party Review Program" and reflects statutory changes under FDARA. This draft guidance is open for public comment, and the FDA welcomes suggestions on which devices should be included as eligible and ineligible for participation in this program, as outlined in FDARA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.