Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence1. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance2.
The line between device CDS functions and nondevice CDS functions has long been unclear. In 2016, the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to carve out certain CDS software functions from FDA regulation as medical devices. The Cures Act exempts certain software functions from the statutory definition of “medical device” under FDCA Section 201(h)(1) “unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purposes of — (i) displaying, analyzing, or printing medical information about a patient or other medical information; (ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and (iii) enabling such health care professional to independently review the basis of such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.”3 To interpret the Section 520(o)(1)(E) carveouts, FDA’s CDS draft guidance published in 2019 adopted a “risk-based” framework in accordance with the recommendations from the International Medical Device Regulators Forum (IMDRF)4. The goal of the framework, said FDA, was to “prioritize patient safety while also recognizing that overregulation could stifle advancements in medical software and clinical support.”5 The final guidance departs from this approach in favor of a new interpretation of the four criteria laid out in Section 520(o)(1)(E)6.
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