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# Two Digital Health Guidances Published
- URL: https://www.fdaweb.com/two-digital-health-guidances-published/
- Published: 2026-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:29:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160442

FDA has published two final digital health guidances. The first, *General Wellness: Policy for Low Risk Devices*, clarifies CDRH’s compliance policy for low-risk products that promote a healthy lifestyle. The [document](https://www.fda.gov/media/90652/download?ref=fdaweb.com) does not apply to products regulated by other FDA Centers or to combination products.

The guidance includes an Introduction, Policy on Low Risk General Wellness Products, General Wellness Products, Determining Risk for General Wellness Products, and Determining Whether General Wellness Products are Within the Guidance Scope.

The second guidance, *Clinical Decision Support Software*, clarifies the scope of FDA’s oversight of clinical decision support (CDS) software intended for healthcare professionals as medical devices. “Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device,” the [document](https://www.fda.gov/media/109618/download?ref=fdaweb.com) says.

The guidance reflects changes to FDA’s approach to CDS software functions made by the Cures Act, which excluded certain software functions from the device definition, the agency says.

“The focus of this guidance is to clarify the types of CDS software functions that are excluded from the definition of a device by the criteria in section 520(o)(I)(E) of the Federal Food, Drug, and Cosmetic Act (FFDCA),” the guidance says. It 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.

The guidance contains an Introduction, Background, Scope, Interpretation of Criteria in section 520(o)(I)(E) of the FFDCA, and Examples.