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# Revise Clinical Decision Support Guidance: Coalition
- URL: https://www.fdaweb.com/revise-clinical-decision-support-guidance-coalition/
- Published: 2018-02-06T12:00:00.000Z
- Updated: 2026-09-14T23:20:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140696

Two stakeholders groups are recommending that FDA make changes to its 12/2017 draft guidance on clinical decision support (CDS) software.

The Clinical Decision Support (CDS) Coalition says FDA should revise and re-issue the draft guidance on CDS that outlined forms of CDS that won’t be regulated based on the degree of human involvement. The draft says CDS software won’t be regulated if doctors can independently review and understand the basis of the software’s decision.

But the coalition [says](http://www.mobihealthnews.com/content/clinical-decision-support-coalition-letter-criticizes-fdas-stance-cds?ref=fdaweb.com) the draft would expand the scope of FDA regulations and fails to take a risk-based approach, covering many low-risk programs already on the market. The coalition’s letter says the agency should: 

- exempt low-risk CDS software from FDA oversight and use international criteria for stratifying risk of CDS software;
- modify the draft to follow provisions of the 21st Century Cures Act that “allows for unregulated software that provides unique insights that the healthcare professional might have to come up with on his or her own, as long as the user has access to the factual basis for the insights”; and
- include more examples of what is and isn’t going to be regulated.

Meanwhile, the American Medical Informatics Association (AMIA) [says](https://www.healthcare-informatics.com/news-item/ehr/amia-urges-more-work-fda-s-decision-support-guidance?ref=fdaweb.com) the draft is well-timed to open a broad discussion over the future of CDS and patient decision support software. The group says it supported development of the draft but now cautions there is “lingering confusion among developers and clinicians trying to determine whether specific CDS software is or is not considered a device.” It also points out that some of the criteria used to determine if a functionality should be excluded is ambiguous.

AMIA recommended that the agency articulate why examples of software are categorized as exempt or not, using the criteria in the 21st Century Cures Act. It also recommends that FDA include discussion about its intended regulatory controls for CDS software considered a device, even if the intended controls are still in development.