Clinical Decision Support Software

On 28 September 2022 the FDA published the final guidance on the scope of oversight of clinical decision support software.

This final guidance clarifies FDA’s thinking expressed in the September 2019 Draft Guidance and focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in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 (“Non-Device CDS criteria”). The final 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.

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