FDA Announces Proposed Recommendations for Fifth Reauthorization of Medical Device User Fee Amendments

On March 22, 2022, the United States Food and Drug Administration (FDA) announced that the agency had reached an agreement with representatives from the medical device industry on proposed recommendations for the fifth reauthorization of the medical device user fee program – Medical Device User Fee Amendments 2023 (MDUFA V).

Under the new agreement, FDA would be authorized to collect at least $1.78 billion in user fees over the course of five years (plus additional funding) for a total of up to $1.9 billion to further improve performance. This funding goes toward “critical resources” to the FDA medical device review program.

The commitment letter was a long time coming and seems to have laid out concessions from both sides. According to RAPS, one of the big disagreements was the FDA’s proposal to fund a total product lifecycle (TPLC) advisory program (TAP) that would include input from outside stakeholders such as health care providers and insurers. Industry believes that outside stakeholders are unlikely to want to participate effectively while the FDA believes it would help companies better understand what is expected of their products in the real world.

The two sides agreed to launch a pilot program that can provide evidence as to whether the idea is successful. In FY 2023, FDA will launch a voluntary TPLC pilot with fifteen products. That number will increase each year and by FY 2027, the number of products enrolled in the pilot can be as many as 225. FDA is also required to publish an assessment of the success of the TAP pilot program by January 30, 2026.

One change in the draft letter is that FDA will be required to either finalize a draft guidance within 5 years of its publication or withdraw it. The letter states that FDA will work to finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within three years of the close of the comment period (as resources permit). However, that percentage aim goes up to 100% after five years.

MDUFA V also notes that at least once per year, both the FDA and industry groups will get together to negotiate how to best use any carryover funds to improve device application reviews.

As has been typical of these MDUFA agreements, the draft includes language to hire independent third-party auditors to evaluate how well FDA is holding up provisions in the agreement.

The proposed recommendations were also published in the Federal Register for public comment, with comments due on April 21, 2022.

Public Meeting

The MDUFA V public meeting will be held virtually on April 19, 2022, to allow the public and interested stakeholders a chance to learn more about the proposed recommendations and provide feedback on them. The final recommendations are scheduled to be delivered to Congress shortly thereafter.

Comments/Statements

“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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement, “The medtech industry is poised to unleash a whole new dimension of innovation for patients in the coming years. Technology is making possible what once seemed impossible. This historic agreement connects increased industry user fees to FDA performance for the first time. It holds innovators to high standards for communicating device performance to the agency. The result will be more timely approval of medical technology earning the FDA’s global gold standard of safety and effectiveness. AdvaMed looks forward to public and congressional consideration of the agreement. The future of life-saving, life-enhancing medical technology for patients is brighter than ever under this vision.”

Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA) also praised the proposal, saying, “Through over a year and a half of negotiations, we have agreed to a good deal for the FDA, industry and most importantly for patients. The agreement will help get the FDA back on track after several years of grappling with the COVID pandemic and introduces new accountability measures related to hiring targets, accrual and use of carryover balance.”