Non-binding Guidance: Key Takeaways from FDA’s Final Guidance on Clinical Decision Support Software

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines FDA’s final guidance on Clinical Decision Support (“CDS”) software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. Join Ropes & Gray FDA regulatory partners Greg Levine and Kellie Combs and counsel Sarah Blankstein as they discuss FDA’s new CDS guidance and provide an overview of key changes, practical implications, and some of the challenges posed by the guidance.