By: Susan Lubejko PhD, Mittal Consulting

The new year has brought big news on the mindset shift that FDA is taking regarding certain AI-powered digital health and wearable wellness products. Following an address to the Consumer Electronics Show in Las Vegas, FDA Commissioner Dr. Marty Makary joined the Fox Business show Varney & Co to share FDA’s most up-to-date public stance on the technologies that fall just shy of the definition of a medical device, which encompasses a wide range of products that are intended to diagnosis or treat a specific disease or other medical condition. At the forefront of this effort are two specific types of technology: AI-powered clinical decision support software and general wellness wearable products.

Clinical Decision Support (CDS) software is software that is meant to provide clinicians with information that support clinician decision making. For instance, a software may be used to compare a patient’s medical information to existing published clinical guidelines to provide the clinician with current validated treatment recommendations for the patient’s diagnosis. Increasingly, CDS software leverages AI to take complex information and retrieve relevant recommendations. Depending on the purpose of the software and the type of data it processes, CDS software may or may not be considered an FDA-regulated medical device.

General Wellness Products are technological products used specifically to promote or maintain a healthy lifestyle or reduce the impact of chronic disease. Wellness products cannot claim to diagnose or treat specific diseases or conditions, but can be used to advance users in wellness categories, such as weight management, fitness, or stress management. Easily recognizable examples of general wellness products are wearable, wrist-worn devices that track activity and sleep. These devices and their capabilities have been under public and regulatory scrutiny over the past year as modern technology has brought detailed health data directly to the consumer.

What is FDA’s current stance on AI-powered decision support and wearable tech?

In FDA Commissioner Makary’s interview, he states that FDA is fully embracing AI in healthcare as a way for patients and clinicians to make better predictions about health outcomes. While the judgement of a trained clinician remains crucial for diagnosis or treatment of a disease, patients should be encouraged to use open-source AI options to gather information for discussion with their physician. If a software is simply providing information, FDA intends to avoid regulation. In the realm of wearables, Dr. Makary shares that consumer-facing products can provide health information to patients, as long as their developers don’t make claims that those devices provide “clinical grade” medical information. Patients should not make serious medical decisions based on the results of a wellness wearable without first speaking to their physician.

Ultimately, the current position on these technologies appears to signal decreased regulation surrounding AI-powered software that provides medical information to patients with or without clinician input and wearable devices that present highly specific health-related metrics to consumers.

How is this being reflected in official FDA guidance and regulations?

Given these recent public statements, medical device developers may wonder how this stance will be reflected in the FDA Guidance documents that describe FDA’s recommendations and current thinking for CDS and wellness products. On January 6^th, 2026, FDA released two new final guidance documents that update the existing recommendations for these product types.

FDA’s Clinical Decision Support Software guidance document was mostly retained from its previous version published in 2022. This guidance primarily defines the four criteria used to determine whether a CDS software is considered a medical device, and is therefore subject to all of the same FDA regulatory requirements as other medical devices, or a Non-Device CDS that can be commercially used without FDA regulation. Importantly, the four criteria have not changed: software that takes in complex signals or medical images for processing before returning a recommendation are medical devices, and Non-Device CDS software must stick to more simple and easily understood metrics that are supported by accepted sources (e.g. vital signs that can be generally communicated in a clinical conversation with known connections to certain disease states).

FDA made the most notable updates to Criterion 3, which determines the types of output a CDS may provide to a clinician. Previously, CDS software that provided information used in time-critical decision making and provided a specific diagnostic or treatment directive would be considered a medical device subject to FDA regulation. In the 2026 update, FDA echoes the sentiment of avoiding specific directives, but leaves the door open for a software to remain outside FDA regulation if it provides a single recommended output when “only one option is clinically appropriate.” For these situations, FDA intends to exercise enforcement discretion. Here, FDA provides examples of such a case, including a software that recommends a single recommended treatment plan for a patient diagnosed with a disease based on simple medical information input when only one outcome would be appropriate for that patient. While the change appears relatively minor in the guidance, instead of CDS software providing a list of options and reference material for a clinician to parse through in their decision making, it may open the door for CDS software to provide specific treatment directives to patients using more opaque, less understandable methods and evidentiary basis without FDA evaluation of the effectiveness of the recommendations.

FDA’s General Wellness: Policy for Low Risk Devices guidance document also saw changes in January 2026. This document is used to help health technology developers decide whether their product is a general wellness product or a regulated medical device. The recent modifications retain the definition of general wellness products and maintain the two categories that these product may fall into: (1) products with claims related to a general state of health that do not make any reference to a specific disease or condition, and (2) products with claims related to a general state of health that make reference to a disease or condition but do not claim to diagnose or treat them (e.g. a product that promotes healthy lifestyle choices known to help patients living with diabetes).

FDA’s biggest modifications to the General Wellness guidance relate to more explicit discussion of non-invasive sensors used in wearable consumer products that output metrics that look a lot like those that come from FDA-regulated medical devices, like blood pressure, oxygen saturation, or blood glucose. FDA signals that it will allow for products performing those measurements to be marketed as general wellness products as long as they are non-invasive, are not intended to provide information on a specific disease, and are not meant to replace an FDA-regulated medical device in the course of a patient’s care. These products cannot claim clinical accuracy or prompt the wearer to specific clinical actions, although they may notify a user to seek evaluation by a healthcare professional when health metrics exceed certain ranges. Finally, FDA provides several new examples of allowable general wellness devices, including wrist-worn wearables that measure blood pressure and minimally-invasive wearable blood glucose sensors that may be marketed in the realm of wellness provided that the developer performs some validation of the measured output and avoids discussion of any specific disease states.

Taken together, Dr. Makary’s public facing statements and signals to device developers and regulatory professionals within the two updated guidance documents indicate the potential for less FDA scrutiny of AI-powered support software and consumer facing wearables in the wellness space. Ultimately, the definitions of the product categories in question have not changed and FDA has maintained its position that any technology that aims to provide diagnosis or treatment is considered a medical device. Importantly, however, some of the subtleties of FDA’s recommendations in these spaces have changed and point to potentially major regulatory and patient care implications for developers, patients, and clinicians.