As the U.S. Food and Drug Administration (FDA) begins the reauthorization process for the Medical Device User Fee Amendments (MDUFA) VI, industry stakeholders, patient groups, and professional societies are outlining their priorities. Covering fiscal years 2028 through 2032, MDUFA VI will set the tone for how device innovation is reviewed, regulated, and funded in the coming years.
At a public meeting held in August 2025, the FDA invited feedback on the performance of MDUFA V and asked stakeholders for input on improvements. From artificial intelligence (AI) oversight to patient engagement, groups across the healthcare ecosystem are calling for reforms that will improve predictability, transparency, and safety.
Evidence Standards for AI and Digital Health
One of the most consistent requests came from the Personalized Medicine Coalition, which praised the progress FDA has made in integrating digital health technologies under MDUFA V. However, the group stressed that the next cycle must deliver clear and publicly available standards for evaluating devices that incorporate software, wearables, and AI/machine learning (AI/ML).
Without transparent evidentiary expectations, developers may face uncertainty in how to design trials or structure submissions. Stakeholders also emphasized the importance of regulatory pathways that are not only predictable but also patient-centered, particularly as AI-based devices expand into diagnostics and personalized care.
Elevating Patient Perspectives
The National Health Council urged the FDA to support development of a voluntary set of patient-centered core outcomes that could be adopted across clinical trials and registries. Establishing consistent, meaningful endpoints would allow better comparison across studies while ensuring that outcomes reflect what matters most to patients and caregivers.
Calls for more transparency around how FDA uses patient input were also highlighted. Suggestions included publishing non-proprietary metrics showing how often patient data is submitted and how it influences final regulatory decisions.
Similarly, the American College of Cardiology recommended expanding FDA’s capacity to review submissions that incorporate patient preference information, while also exploring how AI could be used in post market surveillance for patients with implanted devices.
Investment in Regulatory Science
A recurring theme among professional groups was the need to strengthen regulatory science. The American College of Cardiology specifically called for additional funding for FDA’s Network of Experts Program and collaborative research initiatives such as the Cardiac Safety Research Consortium. These resources, they argued, are critical for developing new methodologies that can keep pace with rapidly evolving technologies like AI and digital health tools.
The National Health Council added that FDA reviewer training should be expanded to cover areas like real-world evidence (RWE), patient-focused device development, and digital health technologies. Enhancing reviewer expertise could help ensure more consistent and efficient decision-making.
User Fee Structures and Broader Changes
Several industry groups also proposed changes to how user fees are collected and used. The Contact Lens Institute suggested creating a separate fee structure for expedited Q Submissions with faster review timelines, while MLM Biologics called for extending small business fee reductions to establishment registration fees to help maintain market diversity.
At the same time, concerns were raised about the sustainability of user fee growth. The Personalized Medicine Coalition noted that user fees accounted for just 11% of FDA device program costs in 2003 but had grown to 44% by 2023, raising questions about long-term balance and transparency in resource allocation.
The Center for Science in the Public Interest (CSPI) also urged FDA to address the regulatory gap for lab-developed tests (LDTs), suggesting that adequate resources should be directed toward enforcement against misleading claims and improper labeling practices.
Looking Ahead
The MDUFA VI discussions make clear that stakeholders want a more transparent, patient-centered, and future-ready FDA device program. From defining standards for AI-driven technologies to ensuring patient voices are consistently integrated, these priorities reflect the broader transformation of medical device regulation.
For manufacturers, the upcoming reauthorization represents both an opportunity and a responsibility: to engage early in the process, align with emerging standards, and anticipate regulatory expectations that may shape innovation for years to come.
At EMMA International, we specialize in helping device companies prepare for these shifts. Whether it’s designing submissions that integrate patient perspectives, aligning with FDA guidance on AI-enabled devices, or navigating user fee structures, our team ensures that innovators can bring safe, effective technologies to market efficiently and compliantly.
