Eye on FDA
A series focused on important FDA and related regulatory developments critical to the life sciences industry.
Search Results
Eye on FDA
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international principles for Software as a Medical Device (SaMD): Clinical Evaluation. FDA’s policy changes lean toward a more deregulatory approach to digital health, including enforcement discretion for certain prediction software, and exemption of certain wearables with non-invasive monitoring from FDA regulation.
Eye on FDA
On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled medical devices. Specifically, FDA is seeking feedback on best practices, methodologies and approaches for measuring and evaluating real-world performance of AI-enabled medical devices from the public.