Posted 03 April 2014
By Alexander Gaffney, RAC
A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions.
Those submissions include premarket applications (PMAs), PMA supplements, biologic license applications (BLAs), BLA supplements and premarket notifications [510(k)s].
The 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 (FDAAA) and the FDA Safety and Innovation Act(FDASIA).
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
- MDUFA date meetings
In March 2013, FDA released a draft guidance document, Types of Communication During the Review of Medical Device Submissions, which explained FDA's expectations for each type of communication.
Notably, those expectations included what the review types are intended for, how they operate, and timelines for review of communications.
For a thorough explanation of the guidance, please see our March 2013 story, "Draft Guidance Increases FDA Flexibility During Interactive Reviews of Medical Device Submissions."
On 3 April 2014, FDA announced that it had finalized its draft guidance, largely keeping it intact despite some protestations within industry.
As FDA recounts in its Federal Register notice, several companies had complained that the final round of the interactive review process described in the guidance was too short-just seven days.
The guidance explains: "As the end of the review cycle approaches, FDA intends to communicate the remaining issues, limiting the applicant's response timeframe to a time specified by FDA, not to exceed 7 calendar days and allowing time for FDA to review the response, so that a timely MDUFA decision can be made."
In comments submitted to FDA, the Orthopedic Surgical Manufacturers Association (OSMA) contended that the timeframe needed to be "evaluated depending on the extent of the additional information [request]." If the deficiency isn't minor, "Seven days may not be sufficient," OSMA wrote.
However, FDA explained that it "did not modify the guidance because this approach is needed in order to appropriately balance the intent of interactive review with FDA's commitment to meet the performance goals agreed upon as part of MDUFA III."
The guidance document otherwise remains almost entirely unchanged, FDA said.
Types of Communication During the Review of Medical Device Submissions (FR)