Industry and FDA Agree on $999.5 Million in User Fees

Industry and the FDA have reached a five-year tentative deal on MDUFA IV (Medical Device User Fees Agreement) fees that reaches almost $1billion in fees.

On August 22, 2015, the FDA and industry announced the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017.

New FDA Programs

Under the new draft agreement, the FDA would use the funds for 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 myDevices 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

Regulated/Regulator Lovefest

Jeff Schuren, M.D, JD, director of the FDA’s Center for Devices and Radiological Health, said, “MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives. This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.”

The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA), and Medical Imaging & Technology Alliance (MITA) also reportedly said that the draft deal builds on the 2012 deal which, for the first time, included metrics to achieve reductions in total review times, opportunities for interactions between FDA and application sponsors before and during the review process, and an independent outside review of the agency’s management review process.

Performance Goals

Performance goals for MDUFA IV include:

• Significant improvements in total review time goals, which will lower the total time goal for 510(k)s and PMAs to historical norms
• Greater accountability through two independent analyses of FDA’s management of the review process—one at the beginning and one at the end of the MDUFA IV timeline—and implementation by the agency of a quality system management approach to the device review process
• Further process enhancements to increase the consistency and timeliness of the review process, including FDA commitments to provide feedback to companies at least five days prior to a pre-submission meeting; a requirement to document the rationale for issuing a deficiency letter; implementation of a standards conformity assessment program; and a pilot to assess the effectiveness of RWE to support premarket activities.

After Congress approves the agreement, this will be the fourth reauthorization of the Medical Device User Fee Agreement (MDUFA)

The FDA says full details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.