FDA Issues Updated Draft Guidance Regarding 510(k) Third Party Review Program

By Allyson B. Mullen –

As our blog readers know, the 510(k) Third Party Review Program has been a bit of a flop in terms of utilization and clearance times (see our previous post here). In Fiscal Years 2013, 2014, and 2015, only 3.2%, 2.2%, and 2.3% of 510(k)s were reviewed by third parties, respectively. See FDA, MDUFA III (FY 2013-2017) Performance, 189, 191, 193 (May 2, 2016).  Needless to say, when we saw FDA published a new draft guidance on the third party review program, we were cautiously optimistic that FDA proposed changes to make the program more useful. Our excitement was short-lived. 

The draft guidance is a combination of the 2013 draft guidance entitled “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I” and the 2004 final guidance “Third Party Review of Premarket Notifications.” The draft guidance is organized in two parts: content regarding the third party review process; and content regarding the authorization and reauthorization of third party reviewers.  The draft guidance also states that it is consistent with the International Medical Device Regulators Forum’s (IMDRF) guidance, to the extent the IMDRF’s guidance is consistent with the FDCA.

The draft guidance outlines the mechanics of the third party review process (previously found in the 2004 final guidance). This content has been updated to reflect recent FDA 510(k) processes, including suggesting that third party reviewers perform an administrative review of 510(k)s utilizing the 510(k) Refuse-to-Accept Checklist, and requiring third party reviewers to comply with FDA’s eCopy Guidance.  The draft guidance also references the Pre-Submission Program stating that the third party reviewer need not be involved in Pre-Submission discussions prior to the 510(k) submission, but the third party reviewer should request that 510(k) applicants inform the third party reviewer of all prior communication with FDA regarding the subject device.  The draft guidance also recommends that the third party reviewer attend Submission Issue Meetings with FDA and the submitted for third party reviewed 510(k)s.  The sections of the draft guidance regarding the program and review process are, however, otherwise the same as in the 2004 guidance.  With no procedural changes, it is doubtful that this guidance will have much (if any) effect on the usefulness of the third party review program. 

The draft guidance proposes significant changes to the accreditation and reaccreditation requirements previously contained in the 2013 draft guidance. Interestingly, there were zero comments to the 2013 draft guidance, however, FDA still considered this major overhaul three years later.  Most notably, the initial accreditation process requires applicants to provide information regarding prevention of conflicts of interest and personnel qualifications.  It is possible that FDA has been requiring this information from applicants during the accreditation process, but it was not mentioned in the 2013 draft guidance.  With these seemingly new requirements for accreditation, we wonder if even fewer new organizations will be able to meet—or try to meet—the standards to become third party reviewers.  The reaccreditation process will utilize the new accreditation information requirements.  Therefore, it is also possible that some third party reviewers may not be able to retain their certification under the apparently more arduous accreditation requirements. 

In short, although we had hoped that the new draft guidance would signal improvements to the 510(k) third party review program, it appears not much has changed, and in fact, it may be more difficult to bring new third party reviewers into the program.