Overview
On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off approach to digital health product regulation. Both updated guidance documents allow for more technologies to be commercialized without FDA premarket review. This move aligns with the agency’s efforts to soften its regulatory approach to promote more widespread usage of such products, especially AI-enabled products, and to bolster the speed at which they can be brought to market.
In Depth
New clinical decision support (CDS) software guidance
In the CDS software draft guidance, FDA presents its current thinking on the four criteria in Section 520(o)(1)(E) of the Food Drug and Cosmetic (FD&C) Act that a software function must satisfy to be exempted from the medical device definition.[1] FDA also clarifies that the guidance does not supersede its digital health policies applicable to software functions that support or provide recommendations to patients or caregivers.
FDA departs from its 2022 guidance most notably by relaxing its view on Criterion 3: “The software function must be intended for the purpose of supporting or providing recommendations to an HCP (health care professional) about prevention, diagnosis, or treatment of a disease or condition.” Under the prior CDS guidance, non-device software could only provide a list of treatment recommendations, as opposed to a clinically appropriate directive. The new guidance now allows for enforcement discretion for single-output software where only one clinically appropriate directive exists. This means that if the software satisfies the other criteria and allows for one clinically appropriate directive, it will be exempt from the medical device definition and fall under enforcement discretion.
The 2022 guidance also made clear that the CDS exemption did not apply to software functions that produced a risk probability or risk score. However, the new guidance strikes this language and even includes an example of a risk score function in its list of examples of software functions that would be subject to enforcement discretion. And yet, under that same example, FDA makes clear that a software function that utilizes input data that does not have established relevance to the diagnostic recommendation will not meet the CDS exemption. Similarly, the guidance states in a different example that a software function that utilizes information that cannot be verified and validated to be from well-understood and accepted sources to generate a specific diagnostic recommendation will also fail to meet the CDS exemption criteria.
Non-invasive wearable monitoring products as general wellness products
FDA also updated its General Wellness draft guidance concerning the classification of certain low-risk non-invasive wearable monitoring products as non-device general wellness products. Under the new guidance, FDA may consider products that use non-invasive sensing to estimate, infer, or output physiologic parameters (such as heart rate variability, blood glucose, oxygen saturation, or blood pressure) to be non-device general wellness products when the outputs are intended solely for wellness uses. The products must additionally meet the following criteria:
- Are non-invasive and not implanted
- Do 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
- Are not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition
- Are not intended to substitute for an FDA-authorized, cleared, or approved device
- Do not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management
- Do not include values that mimic those used clinically unless validated to reflect those values
Products that meet these criteria may contextualize their outputs in relation to general wellness purposes but may not use these outputs to provide specific values for medical or clinical purposes. A product may also use outputs that fall outside of appropriate general wellness ranges to notify a user that “evaluation by a healthcare professional may be helpful,” provided that such notifications do not give specific diagnoses or treatment recommendations and are not ongoing alerts intended to manage a disease or condition. For example, FDA notes in the new guidance that a non-invasive wearable product advertised to elite athletes and intended for monitoring electrolyte balance, among other parameters, labeled for use in an exercise/fitness context only, displays values from cleared devices, and includes a disclaimer that it is not intended for use in diagnosing any condition or disorder, would be considered a general wellness product.
Key takeaways
The updates to both guidance documents signal a continuation of the agency’s efforts to develop industry-friendly regulatory frameworks and encourage consumer access to sophisticated digital health products. Increases in regulatory flexibility could allow certain digital health technologies marketed to clinicians or consumers to enter the market faster, but sponsors looking to avoid device designation should take care to ensure products satisfy the relevant criteria, particularly in areas that are subject to enforcement discretion. For AI-enabled CDS software products, especially those reliant on large language models, sponsors should be aware of the accessibility of training data to ensure that independent HCP review of recommendation bases can actually be completed.
If you have any questions about the revised guidance or how it may impact FDA’s regulation of your business, contact one of the authors of this article or a member of the firm’s Health & Life Sciences Group.