FDA Continues Focus on AI Fronts, Seeks Public Comment on Measuring and Evaluating AI-enabled Medical Device Performance in the Real-World

On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. To inform potential FDA activities in this area, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking feedback to better understand the opportunities and challenges associated with using these innovative technologies in clinical investigations.

On March 30, 2026, the Food and Drug Administration (FDA) published a final guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The guidance provides updated recommendations to industry and FDA on how and when voluntary patient preference information (PPI) may be considered by FDA staff in decision making relating to devices. PPI is not required for FDA’s consideration as part of FDA decision making, but FDA may find it valuable to consider patient viewpoints when the information meets applicable legal requirements. In addition, FDA encourages industry and other interested parties to consider patient experience data in device development and evaluation, including data relating to patient preferences for outcomes and treatments. FDA acknowledges that patient perspective and personal experiences can help FDA evaluate the benefit-risk profile of certain devices throughout the total product life cycle.

On March 20, 2026, the Food and Drug Administration (FDA) announced the agency will hold a public hearing on the Commissioner’s National Priority Voucher (CNPV) Pilot Program, with a Federal Register notice soliciting public comment and scheduling a public hearing for June 12, 2026. As previously noted here and here, the program was announced in June 2025 for the purpose of providing select sponsors with a nontransferable voucher for enhanced engagement with FDA and expedited review for drugs and biologics supporting one or more critical national health priorities, while maintaining adherence to the law’s rigorous safety and effectiveness standards. The national health priorities include public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience initiatives, and affordability improvements. To date, FDA has issued 18 Commissioner’s National Priority vouchers and approved four products to receive these vouchers, including two oncology drugs 44 and 55 days after filing.

On March 18, 2026, the Food and Drug Administration (FDA) issued draft guidance entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance is meant to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. The use of NAMs can improve predictive toxicology in humans and reduce reliance on animal testing.