Clarifying clinical decision support: FDA overhauls guidance to focus on risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS products, substantially revising the draft guidance that was previously released in 2017, "Clinical and Patient Decision Support Software." FDA simultaneously issued a number of final guidance documents updating the medical software regulatory framework developed to implement the 21st Century Cures Act (Cures Act), which we discuss in a companion client update.

The new draft guidance adopts a risk-based framework for evaluating CDS that resembles the approach used by FDA in the "Policy for Device Software Functions and Mobile Medical Applications" guidance. It seeks to clarify FDA's current thinking on the types of CDS software functions that: (1) are not medical devices; (2) meet the definition of a device, but will be subject to FDA's exercise of enforcement discretion (not actively regulated) due to low risk; and (3) are actively regulated. The new draft guidance presents a significant departure from the previously released version, including updates to address industry's concerns with the prior version of the guidance.

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