EMERGO SUMMARY OF KEY POINTS:

• FDA draft guidance clarifies how Third Party Review process aligns with the Medical Device Single Audit Program (MDSAP).
• This guidance complements several IMDRF MDSAP documents issued in 2013, 2014 and 2015.
• MDSAP implementation set for January 2017; US, Australia, Brazil, Canada and Japan are participating.

The US Food and Drug Administration has published new guidance updating its 510(k) Third Party Review program to align with the Medical Device Single Audit Program (MDSAP) launching in 2017. Besides identifying which elements of MDSAP will be added to the Third Party Review program, the draft guidance also explains how the agency recognizes and qualifies third-party organizations to review 510(k) submissions, as well as how third-party reviewers may be suspended or disqualified from the program.

Aligning with MDSAP

With the full implementation of MDSAP set for January 2017 in the US, Australia, Brazil, Canada and Japan, the FDA guidance first addresses how MDSAP principles and guidance devised by the International Medical Device Regulators Forum (IMDRF) will be incorporated into the US agency’s own third-party review system.

Criteria developed by the IMDRF for MDSAP that the FDA guidance is targeting comprise assessment methods for recognizing and monitoring qualified MDSAP auditors, training and competence requirements for assessors of auditing organizations, and decision processes for recognizing auditing organizations as well as revoking such recognition. “In an effort to encourage harmonization, this guidance refers to standards described in the IMDRF documents as criteria FDA will consider for recognition, rerecognition, recognition denial, rerecognition denial, and withdrawal of recognition of (Third Party) Review Organizations under the (Third Party) Review Program,” states the guidance.

The FDA issued the third-party 510(k) review guidance shortly after authorities at the MDSAP published their own call for medical device manufacturer participants ahead of the program’s 2017 launch.

Third-party 510(k) Premarket Pathway

US regulators developed the Third Party Review Program for premarket notifications in order to free up internal resources to focus on higher-risk and more complex devices. The guidance provides a high-level overview of the steps involved in how third-party reviews work:

1. 510(k) registrant submits application to third-party reviewer
2. Third-party review organization evaluates submission
3. Third-party review organization submits recommendation to FDA
4. FDA reviews third-party recommendation
5. FDA issues review decision to third-party reviewer
6. Third-party reviewer passes FDA decision on to registrant

The guidance further provides recommendations from the FDA on how third-party organizations should conduct 510(k) reviews, criteria such organizations should meet in order to qualify for the Third Party Review Program, and recordkeeping practices.

In-depth information on the FDA’s 510(k) review process is available via our whitepaper and video.