FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges.
PMID: 41298848 ·
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Resumo
FDA approval is widely regarded as a benchmark of quality for medical devices. However, concerns persist regarding its regulatory framework for digital mental health devices. This perspective article examined FDA-authorized Software as a Medical Device (SaMD) in mental health, tracing the devices' regulatory lineage through the De Novo and 510(k)-clearance pathways while assessing the quality of evidence that led to their authorization. Many 510(k)-cleared devices lacked direct evidence of effec
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