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Federal guidance defines scope of FDA oversight for AI-enabled wellness products and clinical decision support software

On Jan. 6, the U.S. Food and Drug Administration issued two new guidance documents addressing different categories of health-related technologies. One guidance document focuses on low-risk wellness products, including certain fitness apps and wearable devices such as activity trackers that encourage exercise. The other guidance document addresses clinical decision support (CDS) software. Applicable products, including versions enhanced by AI/ML technologies, can now be classified as non-medical devices and are thereby exempt from stringent regulatory oversight as long as they do not make claims related to disease diagnosis or treatment.

Superseding FDA's "General Wellness: Policy for Low Risk Devices," issued Sept. 27, 2019, explains how FDA interprets section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to software intended to support healthy lifestyle behaviors that are not connected to diagnosing, treating, curing, mitigating, or preventing disease. Under this framework, FDA states that low risk "general wellness products" are not regulated devices, including products that promote overall health or healthy activities or link lifestyle choices to reduced risk or impact from chronic conditions where such relationships are well established.

Similarly, (which supersedes FDA's "Clinical Decision Support Software," issued Sept. 28, 2022) outlines FDA's interpretation of a different provision of section 520, clarifying how FDA evaluates CDS software against four statutory criteria that determine whether such functions are excluded from the definition of a medical device. The guidance also includes examples illustrating how FDA distinguishes between non-device CDS functions, device functions subject to enforcement discretion, and CDS functions regulated as medical devices. 

Summary of FDA guidance changes

• Clarified scope of regulation: FDA clarified how existing statutory exclusions under the FD&C Act apply to general wellness products and CDS software, particularly following amendments made by the 21st Century Cures Act.
• Defined when products are not devices: The guidance explains when certain low-risk, non-invasive wellness products and HCP-focused CDS software functions do not meet the definition of a medical device.
• Refined CDS criteria: FDA detailed how the four statutory criteria in section 520(o)(1)(E) apply to CDS, including expectations around clinician independence, transparency, and appropriate data inputs.
• Clarified enforcement discretion: FDA described circumstances in which it does not intend to enforce device requirements for certain software functions, including some CDS outputs that may present a single clinically appropriate option.

This table lists FDA's clarified criteria for statutory exclusions as devices under section 520 of the FD&C Act regarding general wellness products (wearables) and clinical decision support (CDS) software. 

What does the new guidance mean for manufacturers?

FDA Commissioner  by making it easier to bring certain kinds of wearable devices and clinical decision software to market without a strict regulatory review. While these revised policies do not ease regulatory oversight or lower existing standards, they do give manufacturers greater flexibility. This guidance enables manufacturers to align product design, marketing claims, labeling, and user interfaces within clear boundaries, reducing regulatory risk and streamlining development processes. 

Going forward, product, regulatory, and legal teams can adapt to these changes by taking stock of their existing and planned wellness products, CDS tools, or AI and generative AI capabilities and evaluating them against the updated FDA frameworks, with a focus on aligning claims, labeling, and communications to the clarified regulatory scope.