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Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff September 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C Act. Based on comments received on the September 2019 Draft Guidance, this final guidance clarifies FDA’s thinking expressed in the September 2019 Draft Guidance and focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in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. Additionally, the final guidance provides examples of how FDA applies the Non-Device CDS criteria. These examples identify Non-Device CDS functions that meet all four criteria and device functions that do not meet one or more of the criteria.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6569.

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