Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PubMed

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

PMID: 34156454 ·

S, a, m, u, e, l, , J, , L, e, e, ;, , L, a, u, r, e, n, , C, h, o, ;, , E, y, a, l, , K, l, a, n, g, ;, , J, a, m, e, s, , W, a, l, l, ;, , S, t, e, f, a, n, o, , R, e, n, s, i, ;, , B, e, n, j, a, m, i, n, , S, , G, l, i, c, k, s, b, e, r, g

RevistaJAMA network open
Año
PMID34156454

Resumen

Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. To identify and characterize high-risk devices with pediatric age indications derived from PMA statements. In this cross-sectional study of PMA statements, those statements containing the words indicated or intended fo

Fuente oficial

Ver en PubMed →

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

↑