Digital Health Policy: FDA Relaxes Restrictions over Wearables and AI Decision Making Tools in Two New 2026 Guidances
On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk Devices (General Wellness Guidance) and Clinical Decision Support Software (CDS Guidance), addressing digital health technologies such as wearables and artificial intelligence (AI) “chatbots.” These guidance documents supersede previously issued guidance documents of the same names issued in September 2019 and September 2022, respectively.
The updated guidance documents illustrate FDA’s intent to relax regulatory restrictions over wearables and other “low-risk” products and to address confusion as to the types of health-related claims manufacturers may make when marketing these products. The guidance documents coincide with public comments made by FDA Commissioner Martin Makary in an interview with Fox Business, reposted by @DrMakaryFDA on X, in which Dr. Makary states that “the industry wants clear guidance, markets want predictability, and investors want predictability and that’s what we are going to give them.”
Notably, changes to the General Wellness Guidance directly address the issue of wearables with physiologic parameters (for example, blood pressure, oxygen saturation, blood glucose, and heart rate variability), which were the subject of a warning letter issued to WHOOP, Inc. in 2025. This 2025 warning letter caused a general state of confusion in the industry as to what claims are appropriate for these types of products.
General Wellness Guidance
The changes to the General Wellness Guidance clarify FDA’s existing policy that excludes low-risk wellness tools that encourage healthy lifestyles from regulation as a medical device (such as fitness apps and activity trackers), provided these products do not make claims related to diagnosing or treating diseases or conditions.
The General Wellness Guidance contains lists of examples intended to help differentiate medical devices that are subject to FDA jurisdiction, from general wellness products (which are excluded from the definition of medical device and not subject to FDA regulation). The updated guidance adds additional examples to the lists serving to clarify existing policies and help manufacturers determine the regulatory classification of their products. For example, FDA expressly states that certain products using non-invasive sensing (for example, optical sensing) to estimate or infer physiologic parameters (for example, blood pressure or blood glucose) can be marketed as general wellness products under certain conditions. According to the guidance, manufacturers of these products can make wellness claims (such as informing sleep, activity, or stress) but cannot make medical or clinical claims (such as screening, diagnosing, monitoring, alerting, or managing a disease or condition).
The changes also expand upon FDA’s position on alerts and provide key parameters that manufacturers should consider when developing notification features (for example, a notification informing a user that evaluation by a doctor may be helpful). According to the guidance, certain notification features can be considered general wellness products provided they meet the criteria outlined in the updated guidance. Such criteria requires that the notifications:
- Must not identify or name a specific disease or medical condition;
- Must not characterize the output as abnormal, pathological, or diagnostic;
- Must not include clinical thresholds, diagnoses, or treatment recommendations; and
- Must not provide ongoing alerts or monitoring intended to manage a disease or condition.
CDS Guidance
The changes to the CDS Guidance clarify the extent to which clinical decision support tools may synthesize information, recommend treatment plans, or calculate health-related risks.
The most significant update to the previous CDS Guidance is clarification that FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the Food, Drug, & Cosmetic Act) for functions that provide information to a health care professional to assist the provider with their practice if only one option is clinically appropriate based on the function’s inputs and outputs (assuming the functions otherwise meet the specified parameters in the guidance).
The guidance provides a list of nuanced examples that illustrate acceptable inputs and outputs necessary for software functions to be considered within FDA’s enforcement discretion. For example, one of the examples indicates that a software function that creates a recommended treatment plan (including possible medications) for a health care provider to consider based on a patient’s cognitive impairment diagnosis, comorbidities, age, sex, and patient preferences is a software function for which FDA intends to exercise enforcement discretion (provided a health care provider reviews, revises, and finalizes the treatment plan). According to the guidance, a software function with the same functionality, however, would not fall under this example if the function also analyzes positron emission tomography (PET) scan images because the analysis of a patient’s unique PET scan image would result in a specific preventive, diagnostic, or treatment output or directive rather than an output for which only one option is clinically appropriate.
Deregulation and Innovation – and Following the Guidances
Overall, the updated guidances highlight that FDA is paying increased attention to digital health products while moving further toward deregulation, a move that prioritizes innovation and aligns with the administration’s goals of making the United States a more attractive place for medtech companies to develop and market products.
Interestingly, FDA issued these updated guidance documents without a notice and comment period. As a result, the non-binding guidance documents went into effect immediately upon publication.
Manufacturers should carefully review these guidance documents and ensure their current products and R&D efforts align with FDA’s regulatory priorities. Although FDA appears to be adopting a policy of greater deregulation, it remains imperative that manufacturers continually evaluate the claims they are making to ensure they are not overstating the product’s intended use and/or encouraging users to rely on these products at the expense of medical care by a health care professional.
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