On Friday, October 10, 2019, the US Food and Drug Administration (FDA) issued a notice responding to stakeholder comments to its draft guidance — “510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations” issued September 2018 — reiterating that the program “benefits the public health by allowing new, low-to-moderate risk devices to obtain FDA-equivalent review while enabling FDA to focus more resources on higher risk and more complex devices that necessitate more rigorous review”.
FDA’s implementation of section 523 of the FD&C Act (21 U.S.C. 360m) established a process for authorizing qualified third parties (3PRO) to perform initial reviews of premarket notification (510(k)) submissions for low-to-moderate risk medical devices. In the recently published notice, FDA explains the “objective is for the 3PRO to provide 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 clarifies that “3PROs should provide copies of written communications between the 510(k) submitter and the 3PRO” to the FDA, allowing the Agency to “understand and evaluate whether the 3PRO conducted an FDA-equivalent review” and3PROS “should be involved in any discussions between FDA and the 510(k) submitter regarding the request for additional information. . . whereas their involvement in those discussions ensures the response is evaluated in a timely and efficient manner.”
FDA has also informed that additional revisions to the 2018 draft guidance, have been submitted to the Office of Management and Budget.
To speak with an attorney on how to respond to a Warning Letter and/or bring your tobacco business into compliance with FDA regulations, contact Ann Marie Gaitan, Esq. at 786.440.8115 or via e-mail at amg@ragaitanlaw.