United States of America: Closed consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements

On 7 April 2025, the Food and Drug Administration (FDA) closes the public consultation on its draft Guidance for Industry and FDA Staff regarding the design requirements for Artificial Intelligence-Enabled Device Software Functions. The draft guidance delineates a series of recommendations for the design and development of AI-enabled devices, encompassing model architecture, feature selection, and user interface design. The guidance notes the importance of ensuring that the systems developed are safe, effective and user-friendly throughout the entire product lifecycle. Furthermore, the design of these devices must incorporate mechanisms for risk mitigation, bias prevention, and the ongoing validation of performance in order to ensure reliability and adherence to regulatory standards.