FDA Webview Spotlights Firm Non-binding Guidance Podcast on FDA’s Final Guidance on Clinical Decision Support Software
FDA Webview cited a recent firm Non-binding Guidance podcast in an article about the U.S. Food and Drug Administration’s final guidance on clinical decision support (CDS) software.
The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. The article features a quote from life sciences regulatory & compliance partner and chair Greg Levine.