FDA releases MDUFA V details after industry negotiations

  • March 25, 2022

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002.  AdvaMed lauded the framework earlier in March 2022 after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MDUFA V commitment letter.  For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years.

The deal authorizes the FDA to collect at least $1.78 billion in user fees over five years and up to $1.9 billion if it hits performance targets, compared to around $1.1 billion in the last MDUFA reauthorization.

The FDA will track and report review speed, hiring progress and other metrics to give the industry a better idea of how and where the fees are spent.  An independent contractor will report on the MDUFA workforce, including how many funded positions remain vacant.  The Agency also plans to improve its information technology infrastructure to better support device review.

To expand its capacity and expertise, the Agency will aim for at least 144 new hires in fiscal year 2023, 42 in fiscal 2024 and 24 in fiscal 2025.  Registration fees will decrease if the FDA misses those hiring targets by certain margins.  Registration fees will also decrease if the FDA has more than 13 weeks of operating reserves in its carryover balance at the end of each fiscal year.

The agreement includes a pilot of the new Total Product Life Cycle Advisory Program (TAP) “to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” according to the commitment letter.  The FDA said the TAP pilot — which will be voluntary for applicants in its soft launch — will offer more timely premarket interactions, enhance the device development and review process for everyone involved, and help flag and mitigate product-development risk earlier in the process.

The TAP pilot will also facilitate “regular, solutions-focused engagement between FDA review teams, participants, and other stakeholders such as patients, providers, and payers, beginning early in device development” and “better align expectations regarding evidence generation, improve submission quality, and improve the efficiency of the premarket review process.”

The FDA has scheduled a virtual public meeting for April 19, 2022 and intends to deliver final recommendations to Congress that same month.  Without reauthorization, the program is set to expire at the end of September 2022.  “The agreement underscores the continued commitment by the FDA and medical device industry to prioritize innovation and increase patient access to safe and effective medical devices,” Center for Devices and Radiological Health (CDRH) Director Dr. Jeffrey Shuren said in a news release.  “In addition, MDUFA V represents a substantial investment in the future of the Agency’s medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development.”

REFERENCE:  Medical Design and Outsourcing; 22 MAR 2022; Jim Jammerand

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