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Last week, the U.S. Food and Drug Administration ("FDA") rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final guidance documents released on January 6, 2026 pertain to (1) General Wellness Devices and (2) Clinical Decision Support Software, and supersede previous versions of those guidance documents.1 Then on January 7, 2026, FDA withdrew its guidance entitled "Software as a Medical Device (SAMD): Clinical Evaluation."2
This recent activity marks a significant shift in the FDA's approach to the regulation of digital health and wellness technologies. With the release of two final guidance documents alongside the withdrawal of an older software guidance, the agency is providing the industry with some much-needed clarity on the boundaries of device regulation – refining the definitions and criteria for when products are regulated as medical devices or will be the focus of FDA's enforcement, while also opening pathways for innovation, especially for artificial intelligence ("AI"). This deregulatory push aligns with the administration's agenda to facilitate innovation in the device space.
Summary of Changes to CDS Guidance
The Clinical Decision Support Software ("CDS") guidance describes the four factors considered by the FDA when evaluating whether certain CDS software functions are excluded from the definition of a "medical device." In order for a software function to be excluded from the definition of a device, the software must meet all four criteria.
The first criteria is that the software is not intended to acquire, process, or analyze a medical image or a signal from an invitro diagnostic device or a pattern or signal from a signal acquisition system. The revised guidance clarifies that discrete, episodic, or intermittent point-in-time physiological measurements (e.g., routine vital signs obtained at discrete clinical encounters) generally do not, by themselves, constitute a pattern.
FDA's most significant changes to the guidance are with respect to the third criterion: the software function is intended for the purpose of supporting or providing recommendations to a health care provider ("HCP") about prevention, diagnosis, or treatment of a disease or condition. If a software functions provides a specific preventive, diagnostic, or treatment output or directive, the software function fails this criterion because it is not intended for the purpose of supporting or providing recommendations. However, FDA has clarified in the revised guidance that if only one option is clinically appropriate and the software function otherwise meets all criteria, FDA intends to exercise enforcement discretion for such functions even though the software function may constitute a device. FDAnew examples to illustrate software functions that otherwise meet the criteria but provide only one recommendation that is clinically appropriate.
The revised guidance also removes a discussion on two aspects of software functionality that previously would have affected whether a software function is used to support or provide recommendations to an HCP: (1) the level of software automation and automation bias and (2) the time-critical nature of the HCP's decision-making. By walking back these factors, FDA expands the ways in which software functions could be used by HCP's without qualifying as a medical device.
Summary of Changes to General Wellness Guidance
The 2026 FDA guidance on General Wellness products introduces several important updates to the previous version issued in 2019. Compared with the prior version, the new guidance explicitly addresses advances in non-invasive wearable technology, detailing the conditions under which products that estimate physiologic parameters—such as heart rate, blood pressure, and glucose—may qualify as general wellness items if used exclusively for non-medical purposes.
The updated document offers more nuanced examples and clarifies the distinction between products intended for clinical use and those focused on personal wellness. For example, the guidance cites wrist-worn wearables that assess sleep quality and pulse rate for fitness purposes, and devices that monitor oxygen saturation during recreational activities. It also discusses products that estimate blood glucose to help users better understand their nutritional choices, provided these are not intended for diabetics or clinical management.
Furthermore, it expands criteria related to product labeling, user notifications, and invasive technology, providing a clearer framework for determining whether a product falls under FDA enforcement discretion. Additionally, regulatory references and terminology have been modernized, including updates to quality system requirements. Overall, the 2026 guidance better aligns FDA regulatory policy with technological innovation in consumer health products.
Key Takeaways
Both guidances aim to clarify the boundaries—or, in some cases, grey areas—between products that FDA believes should be regulated as devices and those that should not, further the policy objective to allow companies to operate more freely within the space. Products crossing into diagnostic, treatment directive, or disease management territory become regulated devices, while those confined to general wellness or non-directive recommendation functions are excluded. The updates align with FDA Commissioner Marty Makary's attempt to foster investment and innovation, who recently said at the Consumer Electronics Show that FDA regulation needs to move "at Silicon Valley speed."
The updated General Wellness Guidance more distinctly maps the line between products that do and do not fall under FDA device regulation. Notably, as long as product claims, advertising, and labeling remain focused on general wellness (such as nutrition, fitness, or sleep) and steer clear of disease-specific references or treatment guidance, manufacturers can avoid FDA regulation. These clarifications are especially beneficial from a dealmaking perspective, streamlining diligence processes and lowering barriers to investment and acquisition.
A particularly noteworthy example in the General Wellness Device guidance concerns blood glucose monitoring. Section 3 identifies non-invasive blood glucose sensing devices, such as finger-prick meters, as general wellness products that fall outside FDA regulation, provided the associated advertising and labeling do not reference specific diseases, treatment guidance, or claim clinical equivalence to FDA-approved devices. In contrast, Section 5 addresses wearable blood glucose monitors using microneedle technology for assessing nutritional impacts—such as monitoring how blood glucose levels respond to meals—and specifies that these devices must be explicitly contraindicated for use in individuals with diabetes. This provision suggests that FDA's main concern is the risk of people with diseases relying on these products for medical management. These sections raise the question of whether FDA's focus is on the invasive versus non-invasive nature of the technology, or primarily on the claims made about the product. Ultimately, the guidance suggests that as long as product claims are limited to general wellness uses in non-disease populations—such as nutrition, sleep quality, or athletic performance—FDA regulation does not apply. This emphasis on claims made through advertising and labeling is also a central theme in the CDS Software guidance.
The CDS Guidance builds upon similar principles, emphasizing the decisive importance of claims and product intent. FDA elaborates on the four statutory criteria that dictate whether CDS software is considered a device, with a significant policy shift regarding Criterion 3: software that recommends a single clinical option may now receive enforcement discretion, provided all other criteria are satisfied. This reverses earlier positions, broadening regulatory exclusions for certain health technologies, and further encouraging innovation in digital health.
Ultimately, these changes—and those that have been teased for the future—reflect a clear policy shift for the agency in providing an environment for companies to bring products to market faster and at lower cost. Companies looking at strategic investment in these areas, especially AI-enabled tools in the CDS space, should take a close look at the guidances to assess whether these new policies could further—or hinder—prospective operational decisions.
Footnotes
1. Guidance Documents available here: General Wellness: Policy for Low Risk Devices | FDA; Clinical Decision Support Software | FDA
2. Archived Guidance available here: Software as a Medical Device (SAMD): Clinical Evaluation | FDA
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