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

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

PMID: 33956132 ·

J, o, n, a, t, h, a, n, , R, , D, u, b, i, n, ;, , S, t, e, p, h, e, n, , D, , S, i, m, o, n, ;, , K, i, r, s, t, e, n, , N, o, r, r, e, l, l, ;, , J, a, c, o, b, , P, e, r, e, r, a, ;, , J, a, c, o, b, , G, o, w, e, n, ;, , A, k, i, n, , C, i, l

RevistaJAMA network open
Año
PMID33956132

Resumen

The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices gr

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.

↑