The US Food and Drug Administration (FDA) has released a new draft guidance for industry intended to clarify the types of communication used during the review of medical device product submissions made to its Centers for Devices and Radiological Health (CDRH) and Biological Evaluation and Research (CBER).
The draft guidance is intended to reflect changes undertaken by the agency under two pieces of legislation critical to FDA's mission: the Medical Device User Fee Act of 2007 (MDUFA II) and the Medical Device User Fee Amendments of 2012 (MDUFA III), respectively contained within the FDA Amendments Act and the FDA Safety and Innovation Act.
Both pieces of legislation contained increased funding for FDA in the form of user fees, which the medical device industry agreed to in return for a number of agency reforms, contained in Commitment Letters and the legislation itself.
Chief among those reforms: increased communication with sponsors of medical device applications, which both industry and regulators hopes would be able to resolve issues earlier in the review cycle, making for faster, smoother reviews.
These "communication commitments," as FDA calls them, generally fall into four categories: acceptance reviews, substantive interactions, interactive reviews and MDUFA date meetings.
Acceptance Reviews and Substantive Interactions
Acceptance reviews are intended to lay the groundwork for a successful review, with FDA identifying the lead reviewer or project manager and confirming whether the application has been accepted based on existing criteria (PMA filing criteria/510(k) filing criteria). This stage is applicable to Premarket Approval Applications (PMAs) and panel-track PMA supplements, and communication should occur within 15 days of the filing of the application, generally through fax, email or written letter. If the application is not accepted, FDA should communicate to the sponsor the reasons for its rejection.
Substantive interactions are intended to address both minor and major deficiencies, including ones that have the potential to put the application on hold. These interactions are applicable to all types of device applications-510(k)s, PMAs, PMA supplements, Biologics License Applications (BLAs) and BLA supplements-and occur 60 days after FDA accepts the application for review (90 days for supplements).
During a substantive interaction with FDA, the agency should explain any deficiencies to the sponsor, including whether or not it is cause to place the submission on hold and how it can be resolved.
Interactive reviews are by design the most varied and complex of the communication types covered by FDA's draft guidance, and cover six general goals: 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.
These types of reviews cover 510(k)s, original PMAs, PMA Supplements, original BLAs and BLA supplements, and have no start or stop impact on the review clock.
FDA said it "has found that Interactive Review can be used more broadly than suggested [by an earlier guidance document]." That guidance, Interactive Review for Medical Device Submissions, indicated that "only minor deficiencies" could be considered under an interactive review, with more substantive deficiencies requiring an approvable letter to the sponsor and for the application to be placed on hold.
FDA now thinks differently, it said. "FDA has found that the benefits of Interactive Review could be expanded by using Interactive Review to address deficiencies that are more significant than 'minor,' but that can likely be addressed by the applicant in a time frame that would allow FDA review of the response prior to the MDUFA performance goal for that submission type without placing the submission on hold."
These greater deficiencies might include requests for limited short-term laboratory bench or biocompatibility testing and additional statistical analysis of secondary or tertiary endpoints. These exemptions will need to be cleared by FDA's management prior to communication, it said.
The meetings also include the opportunity for face-to-face interactions and teleconferences, which FDA explained should be carefully planned given the resources required to conduct them.
Other Types of Meetings
A fourth type of meeting, reserved for when FDA misses its MDUFA decision date (100 review days for 510(k) submissions and 20 days after the goal for PMAs and Panel-Track PMA supplements) are intended to lay off all outstanding issues with the application, formulate action items for FDA, outline the date by which FDA hopes to have an approval decision and whether additional meetings with FDA are needed.
A fifth category of meeting-appeals-exists but is not covered by the draft guidance, FDA explained.
Comments on the draft guidance are due to FDA by 3 June 2013.