On January 6, 2026, FDA issued a revised version of the Agency’s Clinical Decision Support Software Guidance, which FDA Commissioner Marty Makary framed as intended to “cut unnecessary regulation and promote innovation.” The new FDA guidance indeed provides some helpful clarifications, including on issues that had been causing confusion since FDA issued the last CDS guidance in 2022. At the same time, the new guidance maintains many of FDA’s existing policies with respect to the CDS category, so it does not represent a fundamental deregulatory shift in FDA’s approach. Here’s what you need to know, and what you should be looking toward next.
Clinical decision support (CDS) software is excluded from device regulation under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FDCA) if it meets all of the following four criteria (which we refer to collectively as “non-device CDS criteria”):
- Criterion 1: The software is 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.
- Criterion 2: The software is intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information.
- Criterion 3: The software is intended for the purpose of supporting or providing recommendations to a healthcare professional (HCP) about prevention, diagnosis, or treatment of a disease or condition.
- Criterion 4: The software is intended for the purpose of enabling the HCP to independently review the basis for the recommendations that such software presents 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 regarding an individual patient.
FDA issued final guidance describing the Agency’s interpretation of these criteria in 2022 (“2022 CDS Guidance”) (see Covington’s summary
here). The 2022 CDS Guidance was criticized by certain stakeholders and notable commentators (including the
current Chairman of the Senate HELP Committee) who argued that FDA’s approach imposed unnecessary conditions and limitations that arguably were not grounded in statutory requirements, thereby inhibiting the development of innovative CDS technologies.
The revised final guidance issued on January 6, 2026 (“2026 CDS Guidance”) supersedes the 2022 CDS Guidance.
1. FDA softens its stance on “singular recommendations,” but keeps overall approach.
- What’s New: FDA will now exercise enforcement discretion for CDS tools that provide a singular output where only one recommendation is clinically appropriate, as long as the tool meets the other non-device CDS criteria. For example, FDA will exercise enforcement discretion for software that recommends a specific FDA-approved drug for an HCP to consider based on the patient’s symptoms and medical history. This is a meaningful clarification from the 2022 CDS Guidance, which narrowly interpreted Criterion 3 to require outputs in the form of a list of options and to exclude software from non-device CDS if the software provided a “specific preventative, diagnostic, or treatment output or directive.”
- Why It Matters: This approach was difficult to implement in real-world clinical practice as it seemed to require developers to include a list of options for the clinician to consider for every scenario, even if only one option was clinically appropriate. This made it challenging to both meet FDA’s interpretation of the statutory criteria and align outputs with established clinical best practices. FDA’s approach in the 2022 CDS Guidance appeared to place significant weight on the statutory reference to “recommendations” (plural) to narrow the scope of CDS that would be exempted from FDA’s purview, which many believe went beyond congressional intent. Notably, FDA has not changed its interpretation of the statute in the 2026 CDS Guidance, but rather is now extending enforcement discretion for these singular outputs.
- Open Questions: While the 2026 CDS Guidance creates an enforcement discretion exception where one recommendation is “clinically appropriate,” it does not define how developers should evaluate when a single recommendation is “clinically appropriate,” leaving open questions as to the true scope of this enforcement discretion carve out.
2. Clinical documentation tools get a new nod.
- What’s New: The 2026 CDS Guidance clarifies that software that analyzes a radiologist’s clinical findings to generate a proposed summary for a patient’s report and a specific diagnostic recommendation may fall under enforcement discretion if a healthcare provider is in the loop. Importantly, however, the tool cannot analyze the underlying image (see Criterion 1) or rely on information that is not from “well-understood and accepted sources” to generate any diagnostic recommendations, and all other non-device CDS criteria must be met.
- Why It Matters: As global health regulators grapple with whether, when, and how to regulate clinical documentation tools, many in industry has been waiting for FDA’s perspective.bWith generative AI transforming documentation workflows, the 2026 CDS Guidance signals openness to innovation in this space.
- Open Questions: FDA has previously signaled that certain software functions that “facilitat[e] clinical documentation” are considered administrative support, not CDS, meaning they would not need to meet non-device CDS criteria. Although the provided example is a meaningful step forward, it remains unclear how FDA views the full spectrum of clinical documentation tools.
3. Emphasis on usability by healthcare professionals & trustworthy sources.
- What’s New: The 2026 CDS Guidance maintains the expanded recommendations from 2022 regarding what information should be provided to HCPs to satisfy Criterion 4, but now places a much stronger emphasis on usability and appropriateness of the information for healthcare professionals. Specifically, FDA stresses that information should be presented in a way that prioritizes decision-relevant details and avoids information overload. At the same time, FDA repeatedly underscores that recommendations must be grounded in “well-understood and accepted sources,” such as clinical guidelines and peer-reviewed literature.
- Open Questions: FDA does not address tools that rely on novel data sources, proprietary algorithms, or emerging evidence rather than what is traditionally considered “well-understood and accepted sources.” Developers also may continue to face challenges in balancing transparency with usability, especially for complex or adaptive algorithms.
4. Surgical edits to time-critical decision making.
- What’s New: The 2022 CDS Guidance interpreted Criterion 3 to exclude any CDS intended for use in time-critical decision making, which some criticized as not an element of the statutory criteria. In the 2026 CDS Guidance, FDA removed this limitation from the discussion of Criterion 3, but added it as an element of Criterion 4, taking the position that software may not allow an HCP to independently review the basis for the recommendation if it is intended for time-critical decision making.
- Why It Matters: Although these revisions technically address previously raised concerns about a narrow interpretation of Criterion 3, the Agency’s overall approach of regulating CDS for time-critical decision making remains the same.
- Open Questions: FDA did not address questions from the 2022 CDS Guidance as to when decisions would be considered “time critical” or not, leaving uncertainty.
5. Silence on consumer-facing tools and AI.
- What’s Missing:
- Consumer- and patient-facing decision support. The 2026 CDS Guidance continues to focus exclusively on HCP-facing CDS, meaning that FDA did not announce any new or clarified policies for consumer-facing tools such as patient decision support, health chatbots, or symptom checkers. The draft CDS guidance documents that preceded the 2022 CDS Guidance included proposed enforcement discretion for certain consumer-facing decision support, but no such enforcement discretion was included in the 2022 CDS Guidance. Those who were hoping any revisions to the 2022 CDS Guidance would include a return of an enforcement discretion policy for at least some consumer-facing decision support will have to wait for future FDA actions (more on that below).
- AI. Despite that FDA announced the 2026 CDS Guidance as focused on AI, the guidance is silent on AI, as was the 2022 CDS Guidance. Although some examples of non-device CDS software functions could be AI-enabled, FDA does not squarely address how the AI-enabled products could meet the CDS criteria, or how FDA will regulate more novel genAI-enabled CDS products such as clinician-facing medical chatbots or AI-generated prescription renewals or referral letters. This omission may be an indication that FDA is still grappling with when and how to regulate AI-enabled tools; for developers, this means continued uncertainty on some of the most pressing issues for AI innovation.
- Open Questions: FDA plans to revise its Policy for Device Software Functions and Mobile Medical Applications in FY26. These future updates from the Agency may more squarely address these tools, such the boundary between symptom checkers subject to enforcement discretion and patient decision support software regulated as devices.
* * *
FDA’s measured approach in the new CDS guidance suggests ongoing dialogue rather than a one-time shift in approach. Of note, FDA issued the 2026 CDS Guidance as a revised final guidance with no formal comment period. Although stakeholders may comment on guidance at any time, as a practical matter, FDA may not act upon such comments until the document is next revised or updated. Our team is closely tracking these developments and would welcome the opportunity to discuss strategic, constructive ways to engage with FDA on the revisions and the open questions they raise.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drugs, and Devices practice.
Back
