Your clinical decision support software may now be regulated by FDA as a medical device

Lexology September 30, 2022
DLA Piper

Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical practice. On September 28, 2022, FDA issued the long-awaited final guidance for the regulation of Clinical Decision Support Software (Final Guidance). The final guidance elaborates on FDA’s interpretation of the statutory guidelines set out in the 2016 21^st Century Cures Act (Cures Act), adds new definitions and, most importantly, provides several new examples that inform software developers on how to navigate the complex regulatory framework surrounding CDS.

The Final Guidance is far more expansive in scope than the 2019 revised Draft Guidance. Most notably, based on our assessment of the Final Guidance, many software products previously not regulated by FDA under...

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