MDUFA VI: Industry, health groups call for clarity on AI, regulatory science investment

As the US Food and Drug Administration (FDA) begins the Medical Device User Fee Amendments (MDUFA) VI reauthorization process, industry, patient, and health professional groups are putting together their wish lists for program priorities, calling for everything from greater incorporation of patient perspectives to more transparency around evidence standards for devices using artificial intelligence (AI).

FDA held a public meeting on 4 August 2025 to start discussions on the MDUFA VI reauthorization, which will cover fiscal years 2028 through 2032. (RELATED: MDUFA VI: FDA eyes growth while industry seeks refinement, Regulatory Focus 4 August 2025).

The agency also opened a public docket to seek comments on the overall performance of the current MDUFA iteration, what features of the program should be discontinued or added in MDUFA VI, and whether changes were needed to the current fee structures.

Clear evidence standards

The Personalized Medicine Coalition, which includes health care industry groups, patient organizations, and clinician groups, applauded FDA for fostering the adoption of digital health technologies (DHTs) in MDUFA V and called on the next iteration of the legislation to include clear, publicly available guidance on the evidentiary expectations, approval pathways, and oversight mechanisms for DHTs and artificial intelligence/machine learning (AI/ML) devices through the FDA’s Center for Devices and Radiological Health (CDRH).

“The rapid growth of DHTs and AI-enabled devices presents opportunities for patients and significant regulatory challenges. The FDA and external stakeholders will benefit from CDRH’s continued work to provide expertise in premarket submissions that include software, interoperable devices, wearables, and AI/ML technologies and to ensure that regulatory pathways are predictable, transparent, and patient-centered,” the Personalized Medicine Coalition commented to FDA.

The Personalized Medicine Coalition also called for MDUFA VI to provider greater transparency around how researchers, health data organizations and other non-industry groups can work with the FDA on pre- and post-market data development and analysis of real-world evidence (RWE).

Incorporating patient perspectives

The National Health Council, a patient advocacy organization, called on FDA to support the development of a voluntary set of patient-centered core outcomes that could be used in device trials and registries. “Establishing consistent, clinically valid, and meaningful outcomes will promote comparability across studies, facilitate pooled analyses, and ensure endpoints reflect what matters most to patients and caregivers,” the group wrote.

Additionally, the group suggested that FDA increase transparency around how it uses patient input. For instance, FDA could test out publishing non-proprietary metrics on patient input into regulatory decisions, such as the type and frequency of patient data submitted and how the data is incorporated into decisions, the National Health Council wrote.

The American College of Cardiology, which represents cardiologists, outlined a series of steps that FDA could take through MDUFA VI to integrate patient perspectives, including expanding the agency’s capacity to respond to submissions that include patient preference information and patient-reported outcomes and exploring the roll of AI in premarket assessment and postmarket surveillance of patients with implanted devices.

Regulatory science

American College of Cardiology called for greater investment in regulatory science and clinical expertise through MDUFA VI, specifically by funding the Network of Experts Program and putting resources toward collaborative research initiatives that bring together regulators, clinicians and industry, such as the Cardiac Safety Research Consortium. Additionally, the group urged FDA to develop new methodologies for evaluating device performance and safety, specifically emerging areas like AI and digital health.

“The [American College of Cardiology] strongly supports continued investment in regulatory science to ensure that the FDA keeps pace with the rapid evolution of medical device development and emerging therapies,” the group commented.

The National Health Council called for additional investment in FDA reviewer training and staffing around patient-focused device development, DHTs, and RWE. “Expanding reviewer expertise in these areas will ensure the consistent application of patient-centered methodologies, strengthen the integration of patient experience and post-market data, and reinforce the evidentiary standards that support timely and efficient review,” the group wrote.

Other changes

Groups also sought changes in user fee structures. The Contact Lens Institute urged the FDA to create a mechanism within MDUFA VI for the submission of expedited Q Submissions that would be supported by a separate user fee and have a shorter response time than the current 70-day timeframe. The group predicted that most submitters would not opt for this pathway but that it would be useful in certain circumstances.

The Contact Lens Institute also asked the agency to spend user fees narrowly for device review activities rather than on broader post-market surveillance and analysis.

MLM Biologics, a company focused on wound closure, commented on the need to extend the small business fee reduction percentage to establishment registration fees. The “relatively modest financial impact” of reducing these fees for small business is balanced by the public health benefit of keeping them in the marketplace, the company wrote.

At the same time the Personalized Medicine Coalition called on FDA to address the “long-term sustainability” of medical device user fees, noting user fees are an increasing proportion of FDA’s budget in this area. “In FY2003, medical device user fees accounted for 11 percent of the MDUFA program total costs, compared with 44 percent in FY2023. Concerns regarding the long-term sustainability of fee growth and the clarity of resource allocation must be addressed,” the group wrote in comments to the agency.

The Center for Science in the Public Interest (CSPI), a consumer watchdog group, called on the agency to pursue regulation of lab-developed tests (LDTs) as part of the MDUFA VI reauthorization. “Both Congress and FDA sought to address the regulatory gap for LDTs in the past by proposing the VALID Act and promulgating the now-vacated LDT Final Rule, respectively, and [the Center for Medicare and Medicaid Services] and FDA have jointly established that FDA is the appropriate authority to oversee regulations of LDTs,” the group wrote.

CSPI suggested that FDA allocate adequate resources to enforce violations of research use only (RUO) labeling in commercially marketed LDTs. Similarly, the agency should identify companies that make false claims to consumers about LDTs, the group wrote.

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MDUFA VI: Industry, health groups call for clarity on AI, regulatory science investment

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