backOn January 6, 2026, the Food and Drug Administration (FDA) published revised, final versions of its guidance documents on general wellness products1FDA, Guidance for Industry and FDA Staff: General Wellness: Policy for Low Risk Devices (Jan. 6, 2026), https://www.fda.gov/media/90652/download [hereinafter “General Wellness Guidance”]. and clinical decision support (CDS) software,2FDA, Guidance for Industry and FDA Staff: Clinical Decision Support Software (Jan. 6, 2026), https://www.fda.gov/media/109618/download [hereinafter “CDS Guidance”]. superseding the prior versions from 2019 and 2022, respectively.
FDA published these updated versions without a public comment period or the release of draft guidance, although both documents state that the public may submit comments at any time for Agency consideration. These updates clarify and expand the scope of enforcement discretion for certain product categories and include new interpretive examples with practical consequences for digital health developers, device manufacturers, healthcare professionals (HCPs), and health IT vendors.
General Wellness: Policy for Low Risk Devices
The 2026 guidance maintains the prior two-factor framework for applying enforcement discretion to “general wellness products”: (i) the device is intended only for general wellness use, and (ii) the device presents a low risk to the safety of users or other persons.3General Wellness Guidance at 2. The updated guidance continues to recognize two categories of general wellness intended uses: (1) purely wellness claims (e.g., weight management, fitness, sleep) and (2) disease-referenced claims tied to a healthy lifestyle where it is well-understood that such a lifestyle may reduce risk or help someone live well with a chronic condition.4Id. at 3.
The most significant update to this guidance is a new section on the boundaries of enforcement discretion for non-invasive sensors that estimate, infer, or output physiological parameters, such as blood pressure, oxygen saturation, blood glucose, or heart rate variability.5Id. at 5-6. This portion of the guidance is directly relevant to the many wearable devices on the market that provide physiologic data for lifestyle-related purposes.
Under the guidance, for a physiologic sensor to qualify for enforcement discretion under the updated general wellness policy, it must meet several criteria. The sensor must:
- not be invasive;
- not be intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- not be intended to substitute for an FDA-cleared or approved device;
- not prompt or guide specific clinical actions; and
- not include values that “mimic those used clinically unless validated . . . to reflect those values.”6Id. at 5.
The guidance clarifies that a physiologic sensor will not be a general wellness product if its labeling, advertising, or functionality references specific diseases or diagnostic thresholds; if it includes alarms or prompts that direct medical management; if it includes claims of equivalency to an FDA-cleared or approved device; or if it is intended for the management of a disease or condition.7Id. at 6. However, the guidance clarifies that a sensor may notify a user that evaluation by a healthcare professional may be appropriate (e.g., because a value has fallen outside of a range appropriate for general wellness uses), provided the notification does not: (1) identify a specific disease or condition; (2) characterize the output as abnormal or diagnostic; (3) include clinical thresholds or treatment recommendations; or (4) provide ongoing alerts or monitoring intended to manage a disease or condition.8Id.
In July 2025, FDA issued a warning letter to WHOOP, Inc. for its Blood Pressure Insights functionality in its wearable product. This feature provided information on the impact of blood pressure on sleep, recovery, and performance.9FDA, Warning Letter to WHOOP, Inc. (July 14, 2025), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025. The warning letter stated that the functionality caused the wearable to be an unapproved device because it was not authorized “for any use, including for the measurement or estimation of a user’s blood pressure.” The warning letter also claimed that real-time blood pressure readings are “inherently associated with the diagnosis of hypo- and hypertension.”
However, FDA’s updated General Wellness Guidance includes a new example of a “wrist-worn wearable product” that measures blood pressure. According to this example, such a product would be subject to enforcement discretion as long as it does not reference a specific disease or medical condition.10General Wellness Guidance at 9. This raises the question of whether WHOOP would receive the same warning letter today, given the non-invasive nature of its wearable and the lack of explicit disease-specific references in its marketing.
Continuous glucose monitors (CGMs) are another category of physiological sensors sometimes marketed for general wellness purposes, such as tracking the impact of food on athletic performance and weight loss, rather than for diabetes treatment. Under the prior General Wellness Guidance, it was unclear whether a CGM could satisfy the “low risk” criterion for enforcement discretion. FDA’s general wellness policy excludes devices that are “invasive,” which FDA defines to mean piercing or penetrating the skin or mucous membranes. A new example in the updated guidance clarifies that a product for “blood glucose measurement” using "minimally invasive microneedle technology” would be invasive because it penetrates the stratum corneum and is therefore not subject to enforcement discretion, even if it is "explicitly contraindicated for use with diabetics and pre-diabetics" and makes only general wellness claims.11Id. at 9-10.
Clinical Decision Support Software
The 2026 CDS Guidance, which supersedes the 2022 version, clarifies the scope of Non-Device CDS under Federal Food, Drug, and Cosmetic Act section 520(o)(1)(E) (i.e., CDS software excluded from the statutory “device” definition). The updated guidance reiterates that to be excluded from the device definition, the software must:
- not acquire, process, or analyze images or signals;
- display or analyze medical information;
- support or provide recommendations to an HCP about prevention, diagnosis, or treatment; and
- enable the HCP12CDS Guidance at 5.
The guidance materially clarifies Criterion 3 (providing recommendations to HCPs). FDA explains that software presenting only one clinically appropriate option would ordinarily fail this criterion; under the previous version of this guidance, CDS that provided a single output would fail Criterion 3, subjecting the software to regulation as a medical device. However, under the revised guidance, FDA will exercise enforcement discretion for such functions if the software meets all other section 520(o)(1)(E) criteria.13Id. at 10-11. This is a significant change for CDS used in areas where the recommended course of treatment is well-established in current clinical practice. The guidance provides concrete examples of recommendations subject to this discretion, including in cardiology, neurology, and risk prediction, opening a new path to market for many types of risk prediction software.
Criterion 4 requires that a Non-Device CDS allow an HCP to independently review the basis for its recommendations. The updated guidance includes a discussion of automation bias (i.e., the “the propensity of humans to over-rely on a suggestion from an automated system”)14Id. at 15. and time-critical use in relation to Criterion 4; in the previous version of the guidance, FDA linked automation bias to Criterion 3. The previous version linked automation bias not only to time-critical situations, but also to CDS that provides a single output or solution. With the revisions to Criterion 3 described above, FDA has eliminated the discussion of automation bias associated with single outputs, but retained the concern about automation bias increasing when users have insufficient time to consider other information. FDA underscores that Non-Device CDS should not be used for urgent decisions where an HCP is more likely to rely on the software's recommendations without an independent review.15Id.
Cross-Cutting Takeaways for Stakeholders
Digital health technologies are rapidly and drastically expanding the scope of information that individuals can access about their health, and it is important for FDA’s regulatory approach to keep pace with this innovation—both to avoid acting as a barrier to advances that can improve individuals’ health, and to continue serving its mission to ensure the safety and effectiveness of devices that patients and providers rely on to make medical decisions. Where to draw those lines, and how best to focus FDA’s finite resources within such a rapidly expanding field, appear to be top-of-mind for current Agency leadership.
The updated guidance documents clarify the extent of enforcement discretion under the general wellness policy and CDS framework, especially for wearable physiological sensors and risk-prediction software. Notably, these updates were issued without the benefit of stakeholder comments on any draft versions. While issuing final guidance may reflect a sense at FDA that it must act quickly to clarify its thinking in this space, it will also be important for the Agency to continue to collect and consider information from patients, providers, and innovators to inform its thinking going forward.
We note that these guidances follow FDA’s recent announcement, from December 2025, of a new pilot program called the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.16Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, 90 Fed. Reg. 56,768 (Dec. 8, 2025), https://www.federalregister.gov/documents/2025/12/08/2025-22190/technology-enabled-meaningful-patient-outcomes-tempo-for-digital-health-devices-pilot. Under this pilot, which FDA will conduct in conjunction with an innovation model from the Center for Medicare and Medicaid Innovation (CMMI), manufacturers of certain digital health devices can ask FDA to exercise enforcement discretion for certain regulatory requirements (e.g., premarket authorization) when their device is offered to or by participants in the CMMI model and while the company is collecting real world data to be used in a future marketing application. The pilot will apply to digital health devices that are intended to be used in conjunction with clinician-supervised outpatient treatment to 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). Although the pilot will impact a relatively small set of digital health technologies, it reflects—along with the recently updated guidances—the Agency’s evolving regulatory approach in this space.
Digital health developers should carefully consider how the updated guidance and TEMPO pilot may create market pathways for new technologies and intended uses that were not previously available. King & Spalding’s nationally ranked FDA & Life Sciences team will continue to monitor developments in this space, and will be well-equipped to advise clients on the strategic legal, regulatory, and business considerations related to these recent activities.