TL/DR –
On January 6, 2026, the U.S. Food and Drug Administration (FDA) updated two final guidance documents: the General Wellness Guidance and the Clinical Decision Support Software (CDS) Guidance. These guides inform industry actions to comply with federal law and have been updated to reflect changes in the FDA’s current position. The General Wellness Guidance maintains its policy of non-examination of “general wellness products” and expands on the definition of such products, as well as including new commentary on wearable health technologies; the updated CDS Guidance clarifies interpretation of section 520(o)(1)(E) of the FD&C Act, which outlines the criteria for CDS software functions.
Updated FDA Guidelines for Wellness Devices and Clinical Decision Support Software
The U.S. Food and Drug Administration (FDA) on Jan 6, 2026, revised its final guidance documents General Wellness: Policy for Low Risk Devices (General Wellness Guidance) and Clinical Decision Support Software (CDS Guidance). The updated documents supplant earlier versions issued in 2019 and 2022 respectively.
FDA guidance documents outline the agency’s current perspective on a subject matter and can help industries align their actions with federal law. Stakeholders who depended on the preceding versions of these documents should scrutinize these updates closely to understand their potential impact on their products and business operations.
General Wellness Guidance
The FDA maintains that it will not examine “general wellness products” to assess their compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as devices. The updated General Wellness Guidance retains the same definition of “general wellness products”, but suggests that more products may be classified as such going forward.
Notably, the FDA has added new commentary on how wearables, such as those using non-invasive sensing technology to gauge physiological parameters, can be deemed general wellness products. However, the FDA has not clarified what it signifies as a range appropriate for general wellness use or how to consult a healthcare professional when the wearable’s outputs are outside this range.
CDS Guidance
The revised CDS Guidance provides insights on the FDA’s interpretation of section 520(o)(1)(E) of the FD&C Act, which states that CDS software functions are not classified as devices provided they satisfy certain conditions. These conditions generally relate to the intended purpose and use of the software in medical applications.
Some significant clarifications in the updated guidance include that medical information about a patient refers broadly to any information used in or related to the patient’s clinical care. Furthermore, the FDA indicated that it may exercise enforcement discretion when a software function offers only a single clinically appropriate recommendation but meets the other criteria under section 520(o)(1)(E) of the FD&C Act. The agency also gives additional flexibility to CDS developers in disclosing information on their proprietary algorithms to users.
Note: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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