By Zachary Brennan – August 23, 2016
The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.
Under the new draft agreement, which is part of the fourth reauthorization of the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the addition of 20 full time employees (FTEs) to establish a new quality management framework, and $30 million to implement a system that improves the quality of real-world evidence (RWE) and linkages among data sources to enable greater use of RWE in the premarket setting.
Other initiatives outlined in the last reauthorization meeting held with industry in May include:
- $12 million to strengthen the Third Party Premarket Review program
- $8.5 million to improve employee retention through incentive pay for managers using existing authorities and policies
- $6 million for an independent assessment of the review process, including a more complete assessment of MDUFA III improvements and outcomes
- Funding for 36 to 43 FTEs to hire reviewers to increase premarket review capacity
- Funding for 34 to 44 FTEs and $3 million to improve the pre-submission process and provide written feedback on 80 to 85% of pre-submissions (depending on number of FTEs supported) within 70 days or 5 calendar days prior to the meeting, whichever comes sooner
- Funding for 28 to 38 FTEs and $1 million to complete 70% of de novo submissions within 120 to 150 days (depending on number of FTEs supported and assuming a workload of 50 de novo submissions per year, which is lower than the assumptions for previous proposals)
- $4.5 million for the development of the my Devices submission and tracking portal
- An unspecified amount of funding for 20 FTEs to hire additional supervisors to reduce the ratio of supervisors to reviewers, thus increasing the capacity of branch chiefs to provide greater oversight and ensure consistency of review procedures
- $4 million to implement more effective recruitment and hiring
- Funding for 13 FTEs and $3.6 million to provide for consistent review of software, streamlining and aligning FDA review processes with software lifecycles, continued engagement in international harmonization efforts related to software review, and other activities related to digital health
- Funding for three FTEs to establish central program management for CLIA Waiver by Application submissions, with an option to fund an additional two FTEs plus $1 million in special operating costs to complete 90% of stand-alone CLIA Waiver applications that do not have a panel meeting in 180 to 150 days (depending on number of FTEs supported), 90% of Dual 510(k) and CLIA Waiver applications in 210 to 200 days, and 90% of stand-alone CLIA Waiver applications that have a panel meeting in 330 to 320 days (pending the review of potential legal impediments)
- Funding for 12 FTEs and $3.5 million to develop internal FDA expertise on patient engagement, support the increased use of patient preference information (PPI) and patient reported outcomes (PROs) in premarket submissions, outline a flexible framework for PRO validation, and clarify the optional use of PROs
- Funding for five FTEs and $2.45 million to establish a conformance assessment program for certified testing laboratories who evaluate medical devices according to certain FDA-recognized standards
