FDA Updates Guidance on Clinical Decision Support

Revised FDA guidance for clinical decision support (CDS) was published Jan. 6; it supersedes the 2022 version. The guidance clarifies which CDS software functions are FDA-regulated or exempt under the 21st Century Cures Act Section 3060 (2016).

For radiology, the 2026 update reaffirms prior interpretations and maintains that any function analyzing medical images to generate diagnostic recommendations is subject to FDA oversight. It also underscores that online AI services offering medical image interpretations directly to consumers generally fall within FDA’s jurisdiction and are not exempt under the Cures Act criteria.

Additionally, the guidance reiterates the agency’s longstanding view that CDS used by referring physicians to apply appropriate use criteria to multiple options during imaging referrals (e.g., under CMS’ Appropriate Use Criteria Program) remains outside FDA regulation. The 2026 revision further clarifies that certain CDS functions—such as those providing a single clinically appropriate recommendation for provider review based on medical record text and clinical guidelines—may remain outside FDA regulation if they meet all statutory criteria.

For more information about federal policies regarding AI and digital health, contact Michael Peters, ACR® Senior Director, Government Affairs.