FDA’s 2026 Guidance Expands Pathway for Low-Risk Digital Health Products—But Caution Remains Essential

The new year has brought notable changes on the regulatory front for life science companies seeking to expand their portfolio of digital health products. In January 2026, the U.S. Food & Drug Administration (FDA) published updated guidance documents addressing two broad product categories: (1) low-risk digital health devices for general wellness use; and (2) clinical decision support (CDS) software. The updates coincide with FDA’s recent launch of the TEMPO pilot for digital health devices, described below. However, as with FDA guidance generally, these updated documents reflect the agency’s current thinking and do not establish legally enforceable rights or responsibilities; they are not binding on the FDA or the public.

General wellness products may include wearables and other tools that track or display metrics such as pulse rate, blood pressure, sleep patterns, and other wellness-related indicators, depending on intended use and marketing claims. Similarly, examples of CDS products discussed in the updated guidance include software functions that provide healthcare professionals with decision-support outputs based on patient symptoms, vital signs, and laboratory values, as well as tools that help estimate future risk based on a patient’s weight, smoking status, and other health parameters.

A key feature of both guidance documents is the FDA’s effort to clarify and expand the extent of enforcement discretion it intends to exercise over these products, which may allow some companies to commercialize qualifying products without first obtaining premarket authorization. Companies seeking to rely on enforcement discretion should carefully assess whether their products fit within the guidance parameters. Otherwise, companies face the potential for regulatory action. Those found to have violated the requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) may also face challenges when defending liability claims in which plaintiffs highlight alleged regulatory noncompliance. 

Together, the updated guidance documents clarify when FDA expects to exercise enforcement discretion for some low-risk digital health products and CDS software functions. Products that meet the definition of a regulated device remain subject to applicable requirements.

The TEMPO Pilot Program

The updated guidance documents were issued in the context of the FDA's newly announced initiative—the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The TEMPO initiative seeks to promote the use of digital devices for individuals managing certain specified chronic diseases, while the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model is a CMS payment model designed to support technology-enabled chronic care with outcome-aligned payments. Digital health devices eligible for the pilot program are limited to those intended to be used in conjunction with clinician-supervised outpatient treatment for patients with conditions in one of four clinical use areas: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes), cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease), musculoskeletal (chronic musculoskeletal pain), or behavioral health (depression or anxiety). These patient populations have been defined by CMS/ACCESS.

The FDA stated that participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world performance data to support ongoing evaluation of device performance and safety. The FDA also indicated it would work with each manufacturer participating in the program to identify circumstances where enforcement discretion may be appropriate. 

General Wellness Product Guidance: Low-Risk Devices

The FDA’s updated General Wellness: Policy for Low Risk Devices guidance (issued January 6, 2026, superseding a prior 2019 version) explains the FDA's Center for Devices and Radiological Health (CDRH) compliance policy for “general wellness products,” defined as products intended for general wellness use that present a low risk to users and others. Note the guidance does not apply to products regulated by other FDA centers (e.g. drugs or biologics) or to combination products. 

A central clarification of the guidance is the statutory carve‑out in Section 520(o)(1)(B) of the FDCA, as amended by the 21st Century Cures Act, under which certain software functions intended “for maintaining or encouraging a healthy lifestyle” and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition are excluded from the device definition under Section 201(h). Practically, that means the FDA’s medical‑device requirements generally do not apply to that software function, so long as the product’s intended use and claims stay within the wellness‑only boundary.

The guidance also emphasizes the FDA’s longstanding enforcement posture: the CDRH “does not intend to examine” low‑risk general wellness products to determine whether they are devices, or, if they are devices, whether they comply with typical premarket and post-market requirements (e.g., registration/listing, labeling, quality system requirements, MDR), provided the product meets the guidance’s criteria. Importantly, inclusion under the policy does not establish that the product is safe and/or effective for its intended use.

A notable expansion in the 2026 update is detailed discussion of wearables and other sensor‑based products that estimate or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability). The FDA indicates it may consider such products to be general wellness products when outputs are intended solely for wellness uses, and only if several guardrails are met: 

• Non‑invasive and not implanted; 
• No higher‑risk intervention/technology; 
• Not intended for disease diagnosis/treatment; 
• Not intended to substitute for an FDA‑authorized device; 
• No functionality or outputs prompting specific clinical action or medical management; and 
• No clinically mimicking values unless appropriately validated. 

Outputs may be displayed as values/ranges/trends and contextualized to wellness domains like sleep, activity, stress, or recovery.

Conversely, the FDA states these products are not general wellness products when intended for medical or clinical purposes (screening, diagnosis, monitoring, alerting, or disease management), or when labeling/advertising/UI/functionality includes red‑flag elements such as references to specific diseases or diagnostic thresholds; alerts prompting clinical action; treatment guidance; claims of “medical‑grade” accuracy or clinical equivalence; or positioning as a substitute for an FDA‑authorized device.

Against this backdrop, it is unsurprising that FDA has scrutinized physiologic‑parameter features marketed in ways that imply clinical utility. For example, the FDA’s 2025 WHOOP warning letter underscored how marketing and feature framing can trigger device classification and enforcement risk. The updated guidance reinforces this message by repeatedly anchoring eligibility to intended use, claims, and how outputs are presented to users.

Clinical Decision Support Software Guidance

The FDA’s Clinical Decision Support Software guidance (issued January 29, 2026, superseding a recently issued January 6, 2026 version) explains the FDA’s current approach to determining which CDS software functions are excluded from the definition of a medical device (“Non‑Device CDS”) and which remain subject to device oversight. 

Under Section 520(o)(1)(E) of the FDCA, a software function is excluded from the definition of a medical device only if it meets all four criteria:

1. The software is not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device (IVD), or a pattern or signal from a signal acquisition system; 
2. The software is intended to display, analyze, or print medical information about a patient or other medical information (e.g., clinical guidelines, peer‑reviewed studies, FDA‑required labeling);
3. The software is intended to support or provide recommendations to a healthcare professional (HCP) about prevention, diagnosis, or treatment of a disease or condition, without replacing or directing the HCP's judgment; and
4. The software is intended to enable the HCP to independently review the basis for the recommendation so that the HCP does not rely primarily on the software output to make clinical decisions for an individual patient.

The updated guidance provides more detailed interpretations illustrating when a CDS function stays outside device regulation versus when it becomes a device software function.

With respect to Criterion 3 and specific software or device outputs, for example, the FDA explains that a CDS tool that provides a specific preventive, diagnostic, or treatment output/directive generally fails Criterion 3 because it is no longer “supporting” HCP judgment in the way contemplated by the exclusion. However, FDA states it intends to exercise enforcement discretion for certain CDS functions that otherwise meet all criteria but provide only one recommendation when a single option is clinically appropriate (and includes multiple examples and “however” carve‑outs).

With respect to Criterion 4 and explainability (including automation bias and time‑critical use), the guidance emphasizes that Non‑Device CDS must provide HCPs enough information—through software output and/or labeling—to independently evaluate the basis of recommendations. FDA highlights that time‑critical decisions and high automation increase the risk of “automation bias,” making independent review less likely; the guidance therefore recommends specific transparency elements (intended use/user/patient population; inputs and data quality requirements; plain‑language algorithm development/validation description; and patient‑specific knowns/unknowns supporting independent review).

As with the general wellness guidance, the updated CDS guidance relies heavily on examples of software functions to show how the FDA applies the criteria in practice, what the FDA considers excluded from device regulation (when all criteria are met), and what may remain subject to medical device oversight. 

The Path Forward

In publishing the updated guidance, the FDA signaled an intent to provide a clearer pathway for certain digital health and software manufacturers to bring some products to market without embarking on a lengthy regulatory approval process. Although not specifically discussed, the new guidance may encourage life science companies to explore innovative medical devices and software, such as those based on artificial intelligence, provided such products otherwise fall within the guidance parameters and FDA’s stated enforcement discretion policies.

Going forward, manufacturers should carefully review the updated guidance and the examples included in each document to determine whether their digital devices or software functions may qualify for enforcement discretion or statutory exclusion from device regulation. Questions of interpretation remain, and product categorization can have significant regulatory consequences. A mistake in categorizing a product could invite enhanced regulatory scrutiny, including warning letters or requests to discontinue marketing. In the event of a liability claim, issues of regulatory noncompliance could arise.

Accordingly, life science companies should confirm that their liability insurance is appropriate for their product’s regulatory posture, including products commercialized without traditional FDA clearance in reliance on enforcement discretion or statutory exclusions.

Despite the need for caution, the updated guidance documents represent an important development in the FDA’s digital health policy and provide additional clarity for companies developing low-risk wellness products and CDS software. A careful review of intended use, marketing language, and product functionality—paired with appropriate insurance alignment—can help companies capture the benefits of the updated guidance while limiting avoidable regulatory and liability exposure.

Authored by Derek Dow, Berkley Life Sciences, Vice President, Western Region Leader