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# Clinical Decision Support Software Guide
- URL: https://www.fdaweb.com/clinical-decision-support-software-guide/
- Published: 2019-09-27T12:00:00.000Z
- Updated: 2026-09-15T01:52:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145111

*Federal Register* notice: FDA has made available a draft guidance entitled “Clinical Decision Support Software.” The document clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act. It describes a risk-based approach for regulatory oversight of CDS software functions that remain devices using the categories defined by a International Medical Device Regulators Forum final document entitled “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” The guidance also provides clarity on the types of CDS software functions on which FDA intends to focus its regulatory oversight for health care providers, patients, and caregivers. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-27/pdf/2019-21000.pdf?ref=fdaweb.com).