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The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.
How has this document caused confusion for industry? How can companies respond?
On this episode, Brad Thompson, Strategic Advisor with EBG Advisors and Member of the Firm at Epstein Becker Green, along with Jessika Tuazon, Member of the Firm at Epstein Becker Green, analyzes the FDA's latest CDS guidance and discuss the challenges industry faces as it attempts to make sense of, and comply with, that guidance.