The FDA’s Center for Devices and Radiological Health has reissued its guidance for clinical decision support (CDS) software in a rewrite that significantly relaxes the regulatory qualifications for this class of software products.
The agency did not release a draft of this new CDS guidance, but this new version has not provoked the kind of backlash
that accompanied the September 2022 version. Sen. Bill Cassidy (D-La.) was among those who found the 2022 guidance to be problematic, stating in an April 17, 2024, press release that the guidance then in effect deviated unacceptably from the terms of the 21st Century Cures Act. Among other things, the Cures Act created significant opportunities for developers to provide medical software outside the FDA’s jurisdiction as seen in Section 3060 of the Act. As we explained in a previous blog, the 2022 version was a significant departure from the related draft guidance, one of several reasons that stakeholders gave the policy poor reviews.
FDA commissioner Marty Makary promoted the new CDS guidance and a guidance for wellness products in a social media post dated Jan. 6, 2026. Makary said the agency must adapt to the times and be proactive rather than reactive with guidance, hinting at an emphasis on less burdensome regulatory standards for health-related software products. The FDA’s new version of its guidance for general wellness will be the subject of an upcoming blog.
The new guidance retains the four general criteria which must all be met for a CDS product to avoid classification as a regulated product. The first criterion, that the software is not intended to process or analyze a medical image or signal from a medical device, is largely the same in both the 2022 and 2026 versions.
The second criterion, that the software is intended to display, analyze or print medical information about a patient, is somewhat altered from the 2022 guidance on one critical point. The 2022 guidance indicated that a CDS would be a regulated product if it provided the type of information that would be communicated between two health care professionals (HCPs), or between an HCP and the patient. The 2026 guidance retains this statement but modifies it by stating that this factor by itself would not qualify the CDS as a regulated product.
One of the more important changes in the 2026 guidance is that a CDS can offer the physician or other health care professional a single diagnosis or course of treatment. The FDA states that while this would still technically qualify the software as a regulated product, the agency will practice enforcement discretion assuming several requirements are met.
One of these requirements is that the software meets each of the other three criteria for exemption from regulation, and the second is that the recommendation is the only clinically plausible option for that patient. The 2022 guidance’s requirement that a CDS must offer more than one possible diagnosis may have proven difficult to fulfill if the patient’s medical history made a particular diagnosis unmistakably clear.
The fourth criterion provides additional leeway for developers of CDS systems, particularly those that leverage artificial intelligence (AI) features. In the 2022 guidance, the FDA had indicated that product labels provide the user with a detailed description of the inputs and the algorithmic logic used to provide the CDS’s results.
While such an expectation might not have proven unduly burdensome for non-AI CDS systems, this kind of information might have been difficult to convey readily for systems that leverage AI, particularly when the AI is based on a machine learning algorithm. The new guidance allows the label to describe the developer’s “general approach” to algorithm development in lieu of a complete characterization of the development process.
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