The FDA third-party review program for 510(k) devices, known as 3P510k, may be revived if recent signals from the agency and Capitol Hill are any indication.
While we at Enzyme do not see the 3P510k program as a universally faster path to market for all 510(k) filings, recent developments suggest that this program could once again provide a useful alternative to the FDA for less complex 510(k) filings.
According to this media report, Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, is interested in expanding the utility of the 3P510k program. Tarver indicated in a May 1 speech that CDRH staff will seek ways to enhance the program to make it a more attractive option for industry. It is not clear what any of the associated changes would consist of, but the timing is interesting. Tarver’s announcement would seem to have the assent of FDA commissioner Marty Makary, whom the Senate confirmed several weeks earlier on March 25.
There is interest in expanding the practicability of the 3P510k program from outside the FDA as well. In September 2024, two members of the House of Representatives, Dan Crenshaw (R-Texas) and Angie Craig (D-Minn.), posted a letter they had sent to Tarver regarding the 3P510k program. The Craig/Crenshaw letter referred to the FDA’s final rule for regulation of lab-developed tests (LDTs), which references the 3P510k program as a method for ensuring that the final rule does not impede access for LDTs. While the LDT final rule has since been overturned in court, the letter from Crenshaw and Craig might still be salient for the FDA regarding the 3P510k program.
Crenshaw and Craig seemingly broadened their inquiry into the 3P510k program from there. They made reference to FDA data in stating that utilization of the program declined from 9.3% of 510(k) submissions in 2008 to 2.4% in 2020, while the number of organizations authorized to conduct third-party reviews now stands at seven. Craig and Crenshaw also made note of FDA commitments to revisit the agency’s re-review of 510(k) applications under the program in both the fourth and fifth device user fee programs. They asked Tarver whether the agency believes that statutory changes might increase utilization of the 3P510k pathway, although Congress is unlikely to pass any related legislation until it ratifies the next user fee program, MDUFA VI, in 2027.
FDA re-review prompted a response
The FDA retains the right to reconsider a 510(k) application cleared by a third party, a fact which may diminish interest in the program. This problem was significant enough that managers at CDRH felt compelled to respond with a plan to reduce the rate of re-review to 15% of applications cleared by a third party. The agency is required to conclude these re-reviews within 30 days, but that adds yet another month to a process that may already be nearly as long, and in some instances longer, than the 90 days required for 510(k) applications filed directly with the agency.
Prior to the FDA Reauthorization Act of 2017, the agency lacked the authority to limit the device types that are eligible for the 3P510k program. The FDA’s re-review report insinuates that more complex devices that require clinical testing were more commonly seen in the program up to that point, one of the factors the agency said drove a higher rate of re-review.
Another limiting factor for the 3P510k alternative is that these third parties cannot access proprietary data for the recited predicate devices. In order to compensate for this, the 2018 re-review plan established an early interaction process that allowed 3P510k reviewers to consult with FDA staff at any point in the review process. The FDA also developed a set of templates that serve as a checklist of sorts to ensure that the sponsor provides all the information necessary to avoid FDA re-review. While these measures are helpful, we recommend that our clients carefully consider whether a third party is likely to be able to process their pending 510(k) application if access to proprietary data from the predicate device or devices is likely to prove critical.
There are advantages to participation in the 3P510k program, which may or may not include a smaller fee schedule. For fiscal year 2025, the FDA charges more than $24,000 for 510(k) applications, although companies with less than $100 million in revenues may pay only approximately $6,000. The FDA may need as many as 60 days to make a determination of whether a manufacturer qualifies as a small business under the $100 million set point, so we urge our clients to apply for a small business status as early in the company’s life as possible.
Timelines may be affected by third-party review
Under the existing device user fee agreement, the FDA has a 90 days to determine whether the application merits a determination of substantial equivalence, although that timeline can expand if the agency requests additional information from the sponsor. These timelines can become more drawn out by the use of the third party, however, as described by the agency’s 3P510k final guidance of November 2024. When the third party submits its recommendations for a 510(k) application to the FDA, any agency requests for additional information are routed through the third party, which then conveys those requests to the sponsor. Obviously this raises the prospect that the 510(k) application will require more time than anticipated.
The final guidance covers convention third-party reviews as well as those for devices submitted as emergency use authorizations (EUAs), and clarifies a few points about whether a device type is eligible for a 3P510k filing. An application for a device implant that is routed through a third party must be accompanied by a detailed explanation as to why that device is eligible for the program.
The guidance also explicitly makes the point that an application that requires disclosure of confidential information held by the maker of the predicate device may be ineligible for the program. However, 510(k)s that require extensive collaboration across scientific disciplines may also be ineligible. The guidance gives several examples of this, including applications that require clinical data or complex, non-clinical data. An example of the latter is an application that entails computational modeling of device performance.
All in all, the 3P510k program is a useful alternative to FDA review of 510(k) submissions, but we advise our clients to carefully consider whether a device is a good candidate. The agency seems determined to take measures to improve the utility of the program, which might be critical if some of the layoffs at the FDA begin to affect 510(k) review times. We can’t predict what sort of changes Tarver had in mind, so the limitations described by the FDA in its November 2024 final guidance should be seen as the most useful set of guiding principles as to whether a device will be a good candidate for the program, at least for the time being.
