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# Group Seeks Clinical Decision Support Guide Rescission
- URL: https://www.fdaweb.com/group-seeks-clinical-decision-support-guide-rescission/
- Published: 2023-02-06T12:00:00.000Z
- Updated: 2026-09-14T18:14:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153715

A citizen petition from the Clinical Decision Support (CDS) Coalition asks FDA to rescind its controversial 9/2022 final guidance on “Clinical Decision Support Software” ([see earlier story](https://www.fdaweb.com/clinical-decision-software-guidance/)) because it violates the Federal Food, Drug, & Cosmetic Act (FD&C Act). The group says FDA should repropose the CDS guidance to follow the statutory language of subsection (o) of the 21st Century Cures Act.

The petition echoes criticism lodged at FDA since it released the final guidance, such as being “more expansive in scope” than an earlier draft version, and many software products previously not regulated by the agency may now be subject to agency oversight ([see earlier story](https://www.fdaweb.com/clinical-decision-software-guide-expands-oversight-attorneys/)). It also departs from familiar concepts like International Medical Device Regulators Form risk levels discussed in the earlier draft and moves to new concepts like “automation bias” that shift the analysis, the [petition ](https://downloads.regulations.gov/FDA-2023-P-0422-0001/attachment%5F1.pdf?ref=fdaweb.com)contends.

Additionally, the CDS Coalition argues that because the final guidance was so far off from what was proposed in the 2019 draft guidance FDA effectively violated the FD&C Act by publishing the final guidance without an adequate notice that gave the public a legitimate opportunity to comment. Specifically, it says the final CDS guidance “removed all discussion of enforcement discretion applied to software used by patients and caregivers. There were a couple of tables in the proposed guidance that have been removed in the CDS (final) guidance, as well as a discussion that was on page 16 of the draft, under the heading Policy for Device CDS Function, which applied a risk-based approach to allow enforcement discretion to be applied to software intended for use by patients and caregivers. All of that is gone in the CDS (final) guidance.”