On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced by the industry. This guidance marks the final version of two previous iterations of this guidance—the first was released in 2017 titled “Clinical and Patient Decision Support Software” and was replaced by the draft issued on September 27, 2019.
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