FDA Addresses Questions on 510(k) Third-Party Review Program

Regulatory NewsRegulatory News
| 15 October 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act.

The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize its resources on higher risk devices.

Comments on the 2018 draft guidance claim that the program “increases the burden on patients and doctors to figure out which devices are safe and which are not.” But FDA counters that the third-party reviewer provides “a review equivalent to that of an FDA reviewer, including making a recommendation, which it submits to FDA.
FDA reviews that information to make a final determination of substantial equivalence and where appropriate, FDA will limit its review to a supervisory-level review. Therefore, the burden to demonstrate substantial equivalence remains unchanged.”

FDA also disagreed with a comment that said the requirement that copies of written communications between the 510(k) submitter and third-party reviewer be provided to FDA was too burdensome.

“FDA believes that to understand and evaluate whether the 3PRO [third-party review organization] conducted an FDA-equivalent review, it is necessary to understand how the 3PRO documented and communicated any deficiencies it found during its review, how the 510(k) submitter responded to those deficiencies, and how the 3PRO evaluated those responses,” the agency said.

Several comments further suggested that the language in the draft guidance is unclear on whether the 510(k) submitter should provide the 3PRO with all subsequent correspondence that the submitter has with FDA.

And FDA clarifies that the 3PRO “should be involved in any discussions between FDA and the 510(k) submitter regarding the request for additional information. FDA does not believe that the continued involvement of the 3PRO creates an unnecessary burden given their responsibilities, whereas their involvement in those discussions ensures the response is evaluated in a timely and efficient manner.”

FDA said it also made a few other clarifications in the draft guidance, which has been submitted to the Office of Management and Budget.

Federal Register Notice


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Tags: 3PRO, 510(k), CDRH, MDUFA

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