FDA Redrafts Framework on Third-Party 510(k) Reviews

Regulatory NewsRegulatory News | 13 September 2018 |  By 

A new framework established in US Food and Drug Administration (FDA) draft guidance maps out how the Medical Device Single Audit Program (MDSAP) could be leveraged for its 510(k) third-party review program and the factors used for determining device type eligibility.
The 37-page draft guidance document—issued Thursday in conjunction with a new plan on re-reviews on 510(k) submissions from third-parties—fulfills Congressional requirements and commitments under the latest reauthorization of the Medical Device User Fee Act (MDUFA).
When finalized, the draft will replace final policies from in 2001 and 2004 on third-party review of premarket notifications and the implementation of such programs and 2016 draft guidance.
The move forms part of a push to extend a least burdensome approach across the total product lifecycle for improved use of internal resources.
“Leveraging high quality, FDA-equivalent outside reviews for lower-risk products can improve the FDA’s overall productivity and enable the agency to focus more of its time and resources on evaluating applications for higher-risk and more complex devices,” Commissioner Scott Gottlieb said.
The drafted policies for early interactions with and re-recognition of third-party organizations are among those that deliver on MDUFA commitments. To ensure compliance with the program’s requirements, these policies should be addressed consistent with MDSAP guidance documents developed by the International Medical Device Regulators Forum (IMDRF), according to FDA.
“These [IMDRF] documents provide the fundamental building blocks of a 3P [third-party] auditing program by providing criteria for the recognition and monitoring of entities that perform regulatory audits and other related functions,” the agency said.
MDSAP—a cornerstone of global harmonization efforts—has seen a significant increase in the number of participating manufacturer sites this year, with the most recent update showing 1,749 listed as of Q1 2018 vs. 788 in 2017.
“There are many shared elements” between FDA’s statutory and regulatory criteria for third-party organizations and the MDSAP documents finalized from 2013 through 2015, the agency said. The draft guidance provides a side-by-side comparison of these elements to aid organizations in leveraging existing documentation of applications submitted to FDA. 
The six factors used by agency staff to determine device type eligibility include the associated risk, as well as whether it is permanently implantable, life sustaining or life supporting and/or requires multifaceted, interdisciplinary expertise to undergo regulatory review.
The remaining three factors relate to the extent to which the device type is well understood as well as the availability of “necessary information to make a well-informed recommendation” and that of post-market data. FDA intends to make all final determinations on these submissions within 30 calendar days, as required under the provisions of the FD&C Act.
Still, the five-part plan laid out in the separately issued document aims to strengthen the program by eliminating re-reviews on at least 85% of all 510(k) submissions from accredited third-party organizations. The plan is centered on ensuring that the eligible device types are appropriate and provide the right tools for timely reviews. 


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