Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.
PMID: 42566203 ·
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Resumo
High-risk medical devices approved through the US Food and Drug Administration (FDA) premarket approval (PMA) pathway may be supported by limited premarket clinical evidence, leaving uncertainties about safety. Whether device, premarket clinical evidence, or regulatory characteristics are associated with subsequent device recalls is unknown. To examine the association between device, premarket clinical evidence, and regulatory characteristics and serious recalls among high-risk therapeutic devic
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