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# 6 FDA Software Exemption Guidances Analyzed
- URL: https://www.fdaweb.com/6-fda-software-exemption-guidances-analyzed/
- Published: 2019-10-08T12:00:00.000Z
- Updated: 2026-09-15T01:55:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145186

Akin Gump attorneys have analyzed a revised FDA clinical decision support (CDS) draft guidance and summarized noteworthy changes in five additional guidances included in a package recently released by the agency to further clarify its interpretation of the 21st Century Cures Act’s software exemptions. The attorneys [write](https://www.akingump.com/en/news-insights/new-draft-policy-on-clinical-decision-support-software.html?ref=fdaweb.com) that the revised CDS guidance “further elaborates on how to make CDS tools appropriately transparent for healthcare professionals such that they are not regulated as medical devices. It also introduces a risk-based framework for regulating CDS software that is a medical device, based on criteria adopted by the International Medical Device Regulators Forum.”

The five finalized guidances and revised draft provide stakeholders with additional clarity on which software-based applications and features are within the scope of the Cures Act exemptions or will otherwise be subject to FDA enforcement discretion, the attorneys write.