Last month, FDA announced a plan for revamping the 510(k) Third Party Review Program (the “Program”), which was outlined in a publication, Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (the “Plan”). One element of the Plan includes the issuance of a draft guidance, “510(k) Third Party Review Program.” With the issuance of this Plan and draft guidance, it appears that FDA is conceding what we and our readers already know; the Third Party Review Program has been less than effective. Ideally, the review and recommendation provided by the Third Party Reviewer reduces the time and resources needed from FDA to make a determination regarding a 510(k) submission. This allows more resources to be focused on high-risk, more complex devices without compromising the quality of review of the lower risk devices. In practice, however, the program has been grossly underutilized, and the few that do participate experience little to no greater efficiency because of FDA’s routine re-review of the submission. To address this issue, the Plan describes how FDA is updating its 510(k) Third Party Review Program.
Overview of the Current Third Party Review Program
In its current form, FDA’s Third Party Review Program, formerly known as the Accredited Persons Program, allows sponsors to submit 510(k) applications for devices with eligible product codes to a Third Party Reviewer, who uses FDA criteria to evaluate the 510(k) submission. The Reviewer then sends the submission to FDA with a recommendation that the device is Substantially Equivalent or Not Substantially Equivalent. FDA has thirty days to make a final determination. However, sometimes FDA re-reviews all or part of a 510(k) submission before making a final determination. All too frequently, FDA requests additional information from the Third Party Reviewer or places the submission on hold pending receipt of additional information. This effectively negates any intended efficiency of the Program.
Overview of FDA’s Proposed Changes
As has been the case, FDA will be limiting eligibility for Third Party Review to certain device types which generally present a lower risk to users. Previously, the devices eligible for Third Part Review were defined by criteria set in statute. The FDA Reauthorization Act of 2017 (FDARA) provided FDA with the authority to tailor the list of eligible devices and directed FDA to provide guidance regarding how a device type, or subset of a device type, will be eligible for Third Party Review. This allows FDA more flexibility to include devices that were previously ineligible for Third Party Review.
The draft guidance document, “510(k) Third Party Review Program,” outlines the factors that FDA will consider when determining which device types are eligible for Third Party Review. These factors include the risk profile of the device, the extent to which a Third Party Reviewer would have access to the information needed to make a well-informed decision, the extent to which the review requires multifaceted interdisciplinary expertise, and the extent to which post-market safety data should be considered. Product codes eligible for Third Party Review will still be identified on FDA’s product code classification database.
The draft guidance also outlines FDA’s process for Recognition, Rerecognition, Suspension and Withdrawal of Recognition for Third Party Review Organizations. This is the process by which a company becomes a Third Party Reviewer and how they demonstrate to FDA that their submissions do not need to be entirely re-reviewed. While Third Party Reviewers must be approved by FDA to participate in the current program, the new Plan appears to set higher standards and hold Reviewers accountable for submissions that require re-review. FDA will conduct periodic audits of Third Party Review Organizations and perform statistical tracking of submission efficiency metrics. In uncharacteristic transparency, these metrics will be published in the Third Party Review Organization Performance Report, posted every quarter to the Third Party Performance Metrics page on FDA’s website. The Report will provide insight into efficiency at all stages of the review process and allow industry to make a more informed decision when hiring a Third Party Review Organization.
FDA’s plan appears well thought out and thorough, leaving us with cautious optimism that it will provide a meaningful alternative to the 510(k) submission process for eligible devices.
 This draft guidance constitutes the reissuance of the draft guidance titled, “510(k) Third Party Review Program – Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” issued on September 12, 2016. See our blog post on that draft guidance here. When final, this draft guidance will supersede “Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and Third Parties,” issued on February 2, 2001; and “Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications,” issued on September 28, 2004.