In this episode of the Diagnosing Health Care Podcast: 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.
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The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces. Subscribe on your favorite podcast platform.