FDA Enforcement Discretion: A Strategic Path to Market for Digital Health and Digital Therapeutics Companies
Nixon Gwilt Law
MAY 29, 2024
Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products. The FDA regulates all medical devices, including SaMD and DTx, but recognizes that not all pose the same level of risk to patients.
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