FDA’s New Guidance on Clinical Decision Support Software

This webinar will provide an overview of the US Food and Drug Administration’s (FDA’s) long-awaited final guidance document for clinical decision support (CDS) software, explaining its interpretation of the CDS software exemption.

We will cover how the final guidance compares to the FDA’s prior draft versions and the potential impacts for developers of digital health software intended for the US market—including artificial intelligence and machine learning software—and other related FDA developments impacting CDS software and digital health.