FDA Issues New Guidance On Communication During Device Reviews

By Ryan Brinks

The U.S. FDA recently released guidelines to help clarify the types of communication the agency will use during the review process for medical devices.

Those guidelines specifically address the submission of premarket applications (PMAs), biologic license applications (BLAs), 510(k) premarket notifications, and other supplementary material.

The guidance addresses changes made under the Medical Device User Fee Act of 2007 (MDUFA II) and the Medical Device User Fee Amendments of 2012 (MDUFA III), which entailed higher user fees in exchange for reforms that would streamline the review process. The reforms included a commitment from the FDA to increase communication with medical device applicants via acceptance reviews, substantive interactions, interactive reviews, and MDUFA date meetings.

According to an article by the Regulatory Affairs Professionals Society (RAPS), the medical device industry and legislators both hope that the increased communication efforts will help “to resolve issues earlier in the review cycle, making for faster, smoother reviews.”

Specifically outlined within the guidelines are FDA expectations for each type of communication, including the reasoning behind each review type, how the processes work, and the timelines for each.

The FDA's guidance document debuted in draft form in March 2013 and is nearly entirely unchanged in its final form.

According to a previous RAPS report, the first draft of the new guidance — which supersedes Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements, created in 2008 — identified six key goals of interactive reviews: “improve sponsor-FDA interactions during review process, prevent unnecessary delays, communicate FDA's concerns to the sponsor, minimize review cycles, minimize deficiency letters and ensure timely responses.”

The only argument against the new guidance documents is the brevity of the final round in an interactive review, which remains at seven days.

According to RAPS, the FDA said that a deadline “is needed in order to appropriately balance the intent of interactive review with FDA’s commitment to meet the performance goals.”