FDA Plans to Streamline Third-Party 510(k) Reviews


Posted September 14, 2018

The Food and Drug Administration (FDA) has announced a framework to streamline third-party reviews of certain lower-risk medical devices. As a “critical component” of this plan, the FDA also issued draft guidance that provides a comprehensive outline of the agency’s approach to improving the third-party review program for certain medical devices.

Reviews of medical device premarket submissions by experts in FDA-recognized third-party organizations are expected to be equivalent in rigor and completeness as agency reviews. Under the framework, the FDA will eliminate re-review of third-party reviews for most submissions.

“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 higher-risk and more complex devices,” said FDA Commissioner Scott Gottlieb, MD, in a statement announcing the plan.

The framework, Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews, is intended to encourage innovation and timely patient access to safe, effective, and high-quality medical devices. “The FDA continues to take steps to encourage advances in medical devices,” Gottlieb said in his statement. “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.”

Draft Guidance Topics and Comment Period

According to the agency, 510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations outlines:

  • Factors to determine which low-to-moderate risk devices are most appropriate for the program;
  • The process the agency would follow when deciding whether to recognize third-party review organizations; and  
  • Specific commitments to Congress authorized to strengthen the program.

These factors are based on the expanded eligibility criteria set forth in the FDA Reauthorization Act of 2017.

The draft guidance replaces the 2016 draft guidance, 510(k) Third Party Review Program. When final, the draft guidance will represent the FDA’s current thinking on third-party reviews.

The draft guidance is open for public comment. The FDA said it welcomes suggestions on which devices should be included as eligible and ineligible for participation in this program. The comment period is open until Dec. 13 in the Federal Register under docket number FDA-2016-D-2565.