FDA “Cuts Red Tape” on Clinical Decision Support Software and Wearable Products for General Wellness

The U.S. Food and Drug Administration (FDA) marked the new year by releasing a pair of updated guidance documents pertaining to clinical decision support (CDS) software and general wellness devices without prior public comment:¹

• The updated “Clinical Decision Support Software” final guidance, which supersedes the 2022 final guidance (which Arnold & Porter covered in an October 2022 Advisory)²
• The updated “General Wellness: Policy for Low Risk Devices” final guidance, which supersedes the 2019 final guidance³

FDA Commissioner Makary described the updated guidances as efforts to “cut unnecessary regulation” and “promote innovation to keep America first.” He also claimed that the guidances will “promote more innovation with [artificial intelligence (AI)] and medical devices.”⁴

The updated guidances might do so by broadening FDA’s interpretation of software functions that either: (1) are exempt from regulation as devices under the 21st Century Cures Act (Cures Act) statutory exclusions for certain CDS and general wellness tools; or (2) do not fall under the Cures Act exemptions but for which FDA intends to exercise enforcement discretion. Consistent with administration goals of accelerating the development of — and removing barriers to — certain AI-enabled products,⁵ the updated guidances suggest that certain types of software functions could be viable use cases for the application of AI under FDA’s new policies, such as those that analyze vast data to deliver health insights.

Main Impressions

Despite FDA’s characterization of these updates as advancing AI policy, we note that neither the 2026 CDS Final Guidance nor the 2026 General Wellness Final Guidance expressly changes FDA’s current approach to AI, suggesting that additional actions on AI are forthcoming. FDA’s evaluation of AI-enabled CDS thus far remains focused on whether the healthcare professional (HCP) can understand the basis of the recommendation, regardless of whether that recommendation is the result of AI/machine learning (ML) techniques or other methodologies. However, the revised policy concerning wearables likely means that more AI-enabled CDS can be made available as non-device CDS, i.e., without FDA review.

Given the commissioner’s statements, developers should anticipate continued developments concerning AI/ML and watch carefully to see if there is consistency in FDA’s statements and guidance around the topic moving forward. For example, FDA is expected to issue an updated version of the “Device Software Functions and Mobile Medical Applications Guidance”. At the same time, FDA Commissioner Makary previewed plans to eliminate at least half of the agency’s software or digital health guidances to make them “more clear, more concise, more modern and more consistent,” but stopped short of detailing which guidances were vulnerable. He also indicated that the agency plans to roll out a new, risk-based AI framework that would move toward a “deregulatory direction” and stressed post-marketing monitoring.⁶

The updates to the 2026 CDS Final Guidance and 2026 General Wellness Final Guidance nevertheless have the potential to impact the regulatory status of a range of digital health products, including ones that may currently be marketed as regulated devices. They also offer more opportunities for developers of CDS and/or general wellness tools to expand or introduce new products without FDA premarket review and with fewer resources, while still maintaining regulatory limitations (e.g., FDA control over CDS and general wellness tools that are more than low-risk or are intended for use in specific situations where the agency continues to believe oversight is important).

The updates are also consistent with a broader theme we are seeing by the current administration to embrace wearable health technologies and attempt to use real-time monitoring and information to identify areas for savings and efficiency in government healthcare programs. The U.S. Department of Veterans Affairs, for its part, has been interested in these technologies for some time, and we anticipate the latest changes by FDA will lead to renewed opportunities for smartwatch and other “wearables” developers to find consumer and government contracting applications for their technologies.

Developers or marketers of wearables and other affected healthcare technologies should evaluate the potential impact of the guidances on marketed or in-development products. And while FDA embraces a broader swath of wellness products as “low-risk” devices, whether these changes will have any impact on insurer coverage of these technologies — a key inhibitor to grown in the wearables market — remains to be seen. It is likely that companies that have gone through FDA clearance or approval will watch carefully for new wellness product market entrants who attempt to make claims similar to cleared or approved products without having gone through FDA review. And liability for product malfunctions or misinterpretation of results will remain key issues, regardless of whether or not an FDA pathway is required or available for these technologies.

We discuss key changes between the updated guidances and their prior versions below.

2026 Clinical Decision Support Final Guidance Key Takeaways

The 2026 CDS Final Guidance clarifies FDA’s thinking with respect to the scope of non-device CDS under the statutory exclusion in 21 U.S.C. § 360j(o), which provides a software function is considered a non-device if it meets four criteria: (1) not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system; (2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information; (3) intended for the purpose of supporting or providing recommendations to a HCP about prevention, diagnosis, or treatment of a disease or condition; and (4) intended for the purpose of enabling the HCP to independently review the basis for the recommendations so that it is not the intent that the HCP rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision.⁷

The 2026 CDS Final Guidance makes major interpretive changes to Criterion 3. FDA introduces a new limited enforcement discretion policy whereby it intends to exercise enforcement discretion toward a CDS software function that provides a single output or recommendation in scenarios where only a single option is “clinically appropriate.”⁸ While FDA does not define “clinically appropriate,” the agency provides illustrative examples of such software functions that would fall within the scope of the enforcement discretion policy.⁹ Importantly, this enforcement discretion policy is not a blanket policy. CDS software functions that provide a single recommendation would remain the focus of FDA’s oversight if, for example, the software predicts the risk of a time-critical event (e.g., cardiovascular event in the next 24 hours) or if it analyzes a medical image or signal in generating the recommendation (fails criterion 1).¹⁰

Select Examples of Software Functions That May Satisfy Criterion 3 But Provide Only One Recommendation That Is Clinically Appropriate

• A software function could satisfy Criterion 3 if it predicts risk of future cardiovascular events for an HCP to consider based on a patient’s weight, current and historical smoking status, blood pressure, and brain natriuretic peptide in in vitro diagnostic test results.
• A software function could satisfy Criterion 3 if it creates a recommended treatment plan, including possible medication(s), for patients diagnosed with cognitive impairment for an HCP to consider based on the patient’s diagnosis related to cognitive impairment as well as potential comorbidities, age, sex, and patient preferences, and that should be reviewed, revised, and finalized by an HCP.
• A software function could satisfy Criterion 3 if it analyzes a radiologist’s clinical findings of an image to generate a proposed summary of the clinical findings for a patient’s radiology or pathology report, including a specific diagnostic recommendation based on clinical guidelines that should be reviewed, revised, and finalized by an HCP.

The 2026 CDS Final Guidance also revises FDA’s temporal view of CDS. FDA considers Criterion 3 to describe a software function that: (1) provides condition-, disease-, and/or patient-specific information and options to an HCP to enhance, inform, and/or influence a health care decision; (2) does not provide a specific preventive, diagnostic, or treatment output or directive; and (3) is not intended to replace or direct the HCP’s judgment.¹¹ FDA no longer excludes per se software functions that are intended to support an HCP’s time-critical decision-making.¹²

The updated CDS guidance elsewhere makes modest changes to FDA’s interpretations of the meaning of “pattern” and “medical information about a patient,”¹³ removes the discussion about automation bias,¹⁴ and tweaks recommendations in Criterion 4 to provide HCPs adequate background information (e.g., “Information that enables an HCP to independently review the basis of provided recommendations is presented in a manner that promotes useability and avoids information overload, including prioritizing the most decision-relevant information and making additional detail available as appropriate”).¹⁵

2026 General Wellness Final Guidance Key Takeaways

Separate from the CDS exemption, the Cures Act exempted from the device definition software intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.”¹⁶ The 2026 General Wellness Final Guidance retains the definition of general wellness products as the 2019 version: General wellness products are products that (1) are intended for only general wellness use, as defined in the guidance; and (2) present a low risk to the safety of users and other persons.¹⁷

FDA has now expanded the scope of general wellness wearables that it will not consider devices or for which the agency intends to exercise enforcement discretion. A general wellness product now could include one that:

• Uses non-invasive sensing (e.g., optical sensing) to estimate, infer, or output physiological parameters that are intended solely for wellness uses
• Is not invasive and not implanted
• Does not involve an intervention or technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied
• Is not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition
• Is not intended to substitute for an FDA-authorized, cleared, or approved device
• Does not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management
• Does not include values that mimic those used clinically unless validated (e.g., through manufacturer testing or peer-reviewed clinical literature) to reflect those values¹⁸

The 2026 General Wellness Final Guidance posits that general wellness products could also display values, ranges, trends, baselines, or longitudinal summaries, and put these outputs in terms of sleep, activity, stress, recovery, or similar domains.¹⁹ Such products could also deliver a general notification to the user when the user’s outputs fall outside of certain ranges, informing the user that an evaluation by an HCP may be helpful.²⁰

Select Examples of General Wellness Products

• A wrist-worn wearable product intended to assess activity and recovery that outputs hours slept, sleep quality, pulse rate, and blood pressure. Sleep is measured via an accelerometer, while pulse rate and blood pressure are measured via a photoplethysmogram. The product has validated values for blood pressure. The product is not intended for use in a medical or clinical context.²¹
• A non-invasive wearable product advertised toward elite athletes and intended for monitoring of several parameters, including electrolyte balance, lactate, and hemoglobin. The product is labeled as for use in an exercise/fitness context only, displays values from cleared devices or ranges from the wearable’s optical sensor, and is disclaimed for use in diagnosing any condition or disorder.²²

The first-listed example may indicate that FDA is relaxing the stance it took just six months ago in its July 2025 Warning Letter to WHOOP, Inc.[[N:FDA then determined that WHOOP’s “Blood Pressure Insights” (BPI) was not a general wellness product, reasoning that BPI reportedly estimates the user’s blood pressure using photoplethysmography, is validated for blood pressure estimation, and is intended for users to understand their mental and physical performance, sleep, and stress, among other things. Following receipt of the Warning Letter, WHOOP publicly responded that it “respectfully disagree[d]; with the FDA’s characterization of BPI as a medical device. WHOOP explained that BPI “is a wellness feature” because it is “designed to help you understand how your body responds to daily life, not to diagnose or treat any condition,” and that “ [w]ellness features like this are common in wearable technology, like tracking your respiratory rate or HRV [heart rate variability.]" U.S. Food & Drug Admin., Warning Letter to WHOOP, Inc. (July 15, 2025).]] (which Arnold & Porter covered in a September 2025 Advisory).²³ FDA now describes a product that shares strong similarities with WHOOP’s BPI as a general wellness product.²⁴

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We will continue to monitor FDA’s adoption of the updated interpretations and recommendations related to general wellness products and software functions. If you have any questions or would like more information, please reach out to one of the authors of this Advisory or your existing Arnold & Porter contacts. 

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.