Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances
Executive Summary
After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.