> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ‘Marked Change’ Seen in FDA Final CDS Guidance
- URL: https://www.fdaweb.com/marked-change-seen-in-fda-final-cds-guidance/
- Published: 2022-10-11T12:00:00.000Z
- Updated: 2026-09-14T18:02:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152944

Three Hyman, Phelps & McNamara attorneys and the firm’s medical device regulatory expert say the FDA 9/28 final Clinical Decision Support (CDS) Software Guidance “represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be non-device CDS or low-risk CDS under enforcement discretion.” In their firm’s *FDA Law Blog*, the writers [say](https://www.thefdalawblog.com/2022/10/the-incredible-shrinking-exemption-fda-final-cds-guidance-would-significantly-narrow-the-scope-of-exempt-clinical-decision-support-software-under-the-cures-act/?ref=fdaweb.com) the final guidance may have significant implications for a wide range of stakeholders, including software developers and healthcare providers, hospitals, patients, and payors.

The post extensively reviews each of the four criteria for non-device CDS software under the 21st Century Cures Act.

The final guidance notably eliminates the category of low-risk device CDS subject to enforcement discretion that had been included in the draft guidance it replaces, the authors say.

“Overall, this long-anticipated CDS guidance outlines a number of dramatic changes from past iterations, many of which would appear to limit the statutory exclusions for CDS software provided under the Cures Act,” the post concludes. “The final guidance will foreseeably lead to more CDS software needing to comply with FDA medical device requirements, including in some cases the requirement for premarket authorization…. Developers and users of CDS software currently in distribution should carefully evaluate the effect of this guidance on their continued distribution and use of such software, respectively, as well as the impact on regulatory strategy for and timeline for availability of software currently in development.”