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ARTICLE · 29 SEPTEMBER 2022

Developers Take Note: FDA Issues Clinical Decision Support Software Final Guidance

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On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software.

United StatesFood, Drugs, Healthcare, Life Sciences
Kyle Y. Faget
Kyle Y. Faget
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On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision Support Software guidance issued on September 27, 2019. The final guidance is particularly important as developers seek clarity regarding the regulatory status of software functions that utilize algorithms to either support or provide clinical decisions for use by health care providers (HCPs). While the draft guidance opined upon clinical decision support software (CDS) intended for use by patients are caregivers, the final guidance noted that FDA's existing digital health policies continue to apply to such software functions such that software functions that support or provide recommendations to patients or caregivers – not HCPs – meet the definition of a device.

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