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# Controversy Seen in CDS Software Final Guidance
- URL: https://www.fdaweb.com/controversy-seen-in-cds-software-final-guidance/
- Published: 2022-11-22T12:00:00.000Z
- Updated: 2026-09-14T18:07:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153247

Three Ropes & Gray attorneys say it is likely that some aspects of the FDA final guidance on clinical decision support (CDS) software released in September will be controversial. Speaking on their firm’s *Non-binding Guidance* podcast, the attorneys [note](https://www.lexology.com/library/detail.aspx?g=cb778211-a6f0-4452-8d44-91295baf0446&ref=fdaweb.com) that the final guidance “represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt some software developers to reassess their CDS products in light of the new guidance.”

The attorneys review the four criteria under which CDS software can be exempted from the 21st Century Cures Act definition of medical device and thus agency regulation. They then describe elements in the final guidance that reflect changes in the four exemption criteria.

They note that the guidance contains many examples within the criteria, some of which provoke additional questions about interpretation.

While stakeholders were hoping that FDA would follow through on a proposed 2022 guidance on risk categorization for software as a medical device, the attorneys say that guidance has been pulled from the 2023 guidance agenda. They say FDA has indicated it will pursue further refinement of the framework through the International Medical Device Regulators Forum (IMDRF). “In the past,” attorney **Greg Levine** says, the IMDRF pronouncements “have been at best confusing when you try to align them with the FDA regulatory regime. So, it seems to me like that was a missed opportunity, unfortunately, and I do think there’s going to be some difficult issues that software developers have to face, and possibly some challenges to FDA’s interpretation, as well.”