FDA Updates Clinical Decision Support (CDS) FAQs: What the Latest Clarifications Mean for Software Developers
The FDA has updated its Clinical Decision Support (CDS) Software Frequently Asked Questions (FAQs), providing greater clarity on regulatory expectations for digital health technologies. This article examines the key FDA clarifications on Non-Device CDS, Software as a Medical Device (SaMD), AI-enabled software, enforcement discretion, and practical considerations for developers navigating the U.S. regulatory landscape.
