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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, Epstein Becker Green attorneys Brad Thompson and Jessika Tuazon analyze the FDA's latest CDS guidance and discuss the challenges industry faces as it attempts to make sense of, and comply with, that guidance.
About the Diagnosing Health Care Podcast
What health care and life sciences decision-makers need to lead, comply, and compete. The health care industry is full of high-stakes legal, policy, and regulatory obstacles. And significant opportunities for those prepared to act on them. Diagnosing Health Care® delivers the intelligence executives, general counsel, and administrators need to navigate both. Part of the Epstein Becker Green Insights Network.
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