FDA formalized guidance on its 510(k) Third Party Review Program this week after a consultation that saw some patient and industry groups criticize varying aspects of the policy allowing some manufacturers to be accredited by outside reviewers. The program is designed to enable faster 510(k) decisions and free up FDA to focus on reviewing higher risk devices.
The final guidance issued Wednesday hews closely to the partly disputed draft, with the most common change being the adoption of 3P510k, rather than 3P, as the abbreviation for the program. FDA did acquiesce to the pushback in some areas, for example by clarifying that review organizations should do assessments equivalent to those carried out by the agency.
Other changes include a slight softening to FDA’s opposition to subcontracting by review organizations and the unpacking of the term “forum shopping” to explain companies cannot send the same 510(k) submission to multiple review organizations.
After taking a stab at draft guidance in 2016, FDA published the most recent draft guidance in September 2018, addressing a FDA Reauthorization Act of 2017 mandate requiring information about how it determines if a device is eligible for the program. In doing so, FDA described the factors that determine eligibility of a device and outlined its approach to the regulation of review organizations.
Scott Gottlieb, then the FDA commissioner, framed the guidance and the program as a way to enable the agency to devote more resources to higher-risk devices.
AdvaMed pushed back on the original draft, saying in January 2017 comments it supports the concept of third party review, but sought changes related to international guidelines and the U.S. user fee law. Specifically, it asked for removal of any reference to the Medical Device Single Audit Program and deletion of FDA's ability to re-review a third party sign off except in extreme cases.
Regarding the 2018 draft, the National Center for Health Research said the changes move the U.S toward an EU-like system that led to safety scandals including one involving the French firm PIP's breast implants, which were found to be made of industrial silicone and led to a major recall. That system, which relies on third parties known as notified bodies, is itself undergoing a massive overhaul to the forthcoming Medical Device Regulation after that and other controversies.
"The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety," the nonprofit research group wrote, also noting the third parties have no requirements to be transparent.
As for the final version, AdvaMed said it was still reviewing the document as of Thursday.
FDA in the final guidance said companies that comply with MDSAP and the International Medical Device Regulators Forum’s Good Regulatory Review Practices are likely to meet the third-party review requirements. The draft version only referenced MDSAP in that section.
The final text features stronger wording about the role of 3P510k review organizations, including new statements that they “should conduct FDA-equivalent reviews of eligible devices ... in accordance with their own quality control practices.”
FDA also added one line stating that a review organization “should determine whether it has the expertise to review the device type” before starting to assess a 510(k) submission, and another line clarifying that they “may not disclose confidential commercial information or any trade secret.”
Elsewhere, FDA made changes that more directly affect companies that submit medical devices for third-party review. One such change affects what happens when a review organization sends FDA a 510(k) submission for a device that is ineligible for the third-party program. Originally, FDA said it would delete the submission if the review organization failed to address its concerns within 180 days. Now, FDA has clarified that the review organization must consult with the device company that filed for 510(k) clearance.
The final guidance supersedes documents issued by FDA in 2001 and 2004.