Tuesday, January 6, 2026, yielded two surprising updates from the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health.
While many experts have been forecasting continued tension between med tech innovators and the agency based on enforcement trends in 2025, FDA released two policy updates that, in fact, purport to ease the burdens on developers of certain wearables and clinical decision support (“CDS”) software tools.
First, FDA released an updated version of its General Wellness: Policy for Low Risk Devices (the “Wellness Policy”), superseding the prior version from September 27, 2019. The new Wellness Policy adds language stating that “FDA may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiological parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses” and subject to several other conditions. To compliment the new language, the Wellness Policy also includes new examples of wearable products that are not considered to be medical devices or that are medical devices but for which FDA does not intend to enforce premarket review requirements.
Second, FDA released an updated version of its guidance on Clinical Decision Support Software (the “2026 CDS Guidance”), superseding the prior version from September 28, 2022 (the “2022 CDS Guidance”). This development is preceded by a history of controversy. FDA’s initial release of the 2022 CDS Guidance sparked pushback from industry, claiming FDA’s interpretation was far too narrow and restrictive on innovation.
In February 2023, the CDS Coalition filed a Citizen Petition calling for FDA to rescind the 2022 CDS Guidance due to its material departure from the draft version that had been issued for public comment. After providing an interim response in March 2023 that the agency needed more time to reach a decision on the Citizen Petition, it was not until January 2025 that FDA issued a formal denial and defended its position as provided in the 2022 CDS Guidance.
Perhaps ironically, FDA’s new 2026 CDS Guidance actually loosens the reins on some of the very positions it staunchly defended just a year earlier in its January 2025 denial of the Citizen Petition. The agency incorporated several clarifications and changes to Section IV of the guidance, addressing interpretation of the four criteria for a CDS software function that, if met, mean it is not a medical device subject to regulation by FDA. The heaviest edits were to Criterion 3, notably:
- Removal of reference to “time-critical decision making” as a feature that causes a software function to fail the Criterion and, thus, be a medical device;
- Addition of a new enforcement discretion policy for certain software functions that produce a single recommendation as an output (which would otherwise cause the product to fail Criterion 3, as multiple recommendations in the software’s output are considered necessary to preserve a provider’s independent clinical judgment) if those software functions satisfy the other three criteria. This change appears to reflect an understanding from the agency that a CDS tool does not automatically compromise a provider’s independent clinical judgment if it only produces one clinically relevant output, as the provider must still review the recommendation and determine whether it is appropriate for the patient; and
- Deletion of the prior statement that FDA considered software that provides information that a specific patient may exhibit signs of a disease or condition or identifies a risk probability or risk score for a specific disease or condition as not satisfying Criterion 3.
At a high level, additional revisions include updates to Criterion 1 to clarify the definitions of “signal acquisition system” and “patterns,” providing more detail for industry; updates to Criterion 2 making the language describing “medical information about a patient” more flexible; and updates to Criterion 4 easing the obligation of developers to ensure the provider using the CDS tool understands the basis of the tool’s recommendation.
Interestingly, both of FDA’s updates were issued without a notice and comment period, which could be leveraged by parties in opposition to the changes despite their apparent benefit to the med tech industry.
EBG is continuing to review and analyze these significant developments. If you have questions, please reach out to the author of this blog or your contact at EBG.
