Health Affairs January 6, 2025
As artificial intelligence and machine learning (AI/ML) advances, increasing numbers of manufacturers will incorporate them into medical devices. So far, the U.S. Food and Drug Administration (FDA) has already authorized the marketing of more than 950 AI/ML-enabled devices, and the agency is receiving new submissions at a rapid pace. Although the FDA has been actively engaged in addressing new regulatory challenges posed by AI/ML, such as the delineation between device and non-device software functions, most of its actions do not have the official force of law.
Recently, the Supreme Court decided Loper Bright Enterprises v. Raimondo (2024), which overruled a longstanding legal doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Although theoretically Loper Bright directly...
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