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- Regulatory Scrutiny and the Software as a Medical Device (SaMD) FrameworkThe proliferation of digital mental health tools has necessitated the development of a specific regulatory framework, primarily managed by the U.S. Food and Drug Administration (FDA). The FDA differentiates between low-risk "general wellness" apps, which fall outside their oversight, and those intended to diagnose, mitigate, treat, or prevent a disease, classifying the latter as Software as a...0 Commenti 0 condivisioni 750 Views
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