FDA Faces Pressure to Establish AI Medical Device Labeling Standards and Validation Protocols
Experts call for improved FDA labeling standards and validation for AI medical devices.
Key Points
- • Over 1,000 AI medical devices authorized by the FDA lack clear labeling standards, according to Sara Gerke.
- • AI tools often perform poorly in real-world settings post-approval, emphasizing the need for robust validation frameworks.
- • The FDA treats AI as traditional medical devices, complicating necessary updates and ongoing validations.
- • A recommended labeling system could enhance user literacy much like nutritional labels do for food products.
On July 9, 2025, experts highlighted the urgent need for the Food and Drug Administration (FDA) to enhance its regulatory framework concerning AI-powered medical devices, citing significant gaps in both labeling standards and validation processes. A recent paper by Sara Gerke from the University of Illinois Urbana-Champaign argues that over 1,000 AI medical devices currently authorized by the FDA lack comprehensive labeling standards, which hinders transparency and safe usage. Gerke suggests implementing labeling systems akin to nutrition labels used for food products, advocating for the introduction of 'AI Facts' labels and a 'front-of-package' labeling system to improve user understanding regarding the performance and risks associated with these devices.