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Organizational Policy/Guidelines

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff.

Rockville, MD; US Food and Drug Administration: September 28, 2022.

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October 3, 2022
Rockville, MD; US Food and Drug Administration: September 28, 2022.

Clinical decision support (CDS) systems must be reliable to be safe. This final guidance outlines CDS scope and software functions used to define their qualification as a device regulated by the US Food and Drug Administration. 

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Rockville, MD; US Food and Drug Administration: September 28, 2022.

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