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FDA Guidance Clinical Decision Support Software

  • 1.  FDA Guidance Clinical Decision Support Software

    Posted Sep 28, 2022 02:40:00 AM
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    Hi All,

    FDA just published Guidance Clinical Decision Support Software

    The purpose of this guidance is to describe FDA's regulatory approach to CDS software functions. The Agency's approach reflects changes to the FD&C Act made by the Cures Act, which amended section 520 and excludes certain software functions from the device definition. The focus of this guidance is to clarify the types of CDS software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act. This guidance further clarifies that FDA's existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. 5 For example, some decision support software functions may be identified in other guidance documents as software functions for which, based on our current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and approval requirements. This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.

    Michael Roza CPA, CISA, CIA, MBA, Exec MBA