Industry representatives have endorsed measures that would streamline the FDA’s premarket review process, but said they will be watching closely for tangible results in exchange for a $320 million increase in user fees.
They especially cited provisions in the draft agreement that would cut time-to-decision goals for 510(k) submissions from 124 to 108 days and for premarket approvals from 385 to 290 days by fiscal year 2022. The agreement also would make premarket reviews more consistent and transparent, increase funds for recruiting and retaining FDA staff, and set aside money for key information technology improvements.
The Nov. 2 public meeting was one step in the process of finalizing the draft recommendations. The FDA will accept public comments for 30 days following the meeting, incorporate any necessary changes, and transmit final recommendations to Congress by Jan. 15, 2017. Congressional passage of MDUFA IV is expected by the summer of 2017.
Under MDUFA IV, the FDA would collect $999.5 million in user fees over five years (up from $679 million under MDUFA III) for a host of process improvements long sought by industry.
FDA Associate Commissioner for Planning Malcolm J. Bertoni said at the meeting that the agreement includes a goal to provide written feedback on at least 1,950 pre-submissions within 70 days, or five calendar days prior to the scheduled meeting, whichever comes sooner, in FY 2022.
The FDA also will hire additional staff to improve de novo submission procedures. In particular, the de novo performance goal would increase from 50 percent of submissions being reviewed within 150 days in FY 2018 to 70 percent in FY 2022. Currently, 40 percent of de novo submissions are reviewed within 150 days.
FDA funding needs were based on the most recent available annual cost data from fiscal year 2015. In addition, the “fifth-year fee offset” clause was eliminated to allow the agency to spend all the fees it collects — even if it collects more than expected — so it can take on additional work.
MDUFA IV lowers the 510(k) fee for small businesses by 5 percent compared to fiscal year 2016 despite making significant fee increases in other areas.
In addition, Bertoni said the agreement calls for a dedicated team to establish a quality management framework for the premarket submission process and to conduct routine quality audits. The framework will include infrastructure, senior management responsibility, resource management, lifecycle management and quality management system evaluations.
The FDA also plans to make IT improvements to facilitate new performance goals and reporting, enhance IT infrastructure to enable collection and reporting on structured data, develop and maintain a secure Web-based application that allows sponsors to view individual submission status in near-real time, and develop structured electronic submission templates as a tool to guide industry’s preparation of premarket submissions.
Also under MDUFA IV, the agency will strengthen its Accredited Person Premarket Review Program by improving training for third-parties reviewers, redacting predicate review memos for use by third parties during their reviews, conducting audits of third-party review quality, and publishing assessments the performance of individual third parties. Bertoni said the goal of these measures is to eliminate routine re-review by FDA of third-party reviews.
‘Reasonable Contribution from Industry’
Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, said her group fully supports MDUFA IV, which “builds on the success” of MDUFA III. She particularly cited the time-to-decision goals for 510(k) submissions and premarket approvals, as well as provisions calling for the FDA to specify the particular guidance, regulation, or standard that forms the basis of a deficiency letter.
Trunzo said the substantial fee increase from MDUFA III “represents a reasonable contribution from industry” in exchange for the process and efficiency improvements. “The end result of this agreement is a win for our patients, for FDA, and for innovation,” she said.
Mark Leahey, president and CEO of the Medical Device Manufacturers Association, also praised MDUFA IV, but said that industry expects a real return on its investment of user fees. “If the FDA can execute on their commitments, it will benefit all parties,” he said.
Like Trunzo, Leahey said the process improvements for deficiency letters will help industry respond appropriately, because the exact nature of alleged deficiencies was not always clear in the past. Specifying which standard was allegedly violated will show manufacturers “where they might have fallen short,” but also “provide a check for FDA” when it claims something went wrong, he said.
Megan Hayes, director of regulatory and standards strategy for the Medical Imaging & Technology Alliance, said in an interview after the meeting that MDUFA IV’s provisions — although welcome in principle — need to be “carefully evaluated” to see if they really do make the premarket review program faster, more transparent and more accountable.
“We understand that FDA’s overall mission is larger than that, but we really believe MDUFA should provide additive funds to improve the premarket process” above all other considerations, she said. — Jeff Kinney