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PubMed

US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement.

PMID: 39382899 ·

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RevistaJAMA network open
Año
PMID39382899

Resumen

The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients. To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to b

Fuente oficial

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Datos obtenidos de PubMed / NCBI. Para consultar el texto completo y la información más reciente, remítase siempre al registro oficial.

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