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FDA final Clinical Decision Support guidance significantly expands on interpretations under 21st Century Cures Act

Almost three years after the last draft was released, FDA has now published a final guidance on Clinical Decision Support (CDS) software functions. The new final guidance includes comprehensive examples of when the FDA considers certain CDS functions to be medical devices and provides new and expanded interpretations of how FDA will apply statutory provisions of the 21st Century Cures Act.

The FDA’s system for regulating software as a medical device (SaMD) under 21st Century Cures

  • The statutory definition of what is – and what is not – a medical device: The 2016 21st Century Cures Act updated provisions in the Federal Food, Drug and Cosmetic (FD&C) Act to better clarify what types of software are considered to be within the FDA’s regulatory purview as a medical device. Importantly, that statutory update categorized whether products were in or out of the regulatory scope of the FDA’s oversight by function – meaning that a single software product could have multiple functions, some of which may be medical devices while others are not medical devices.

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