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

US FDA best practices for initiating early feasibility studies for neurological devices in the United States.

PMID: 34087794 ·

R, o, b, e, r, t, , H, e, r, r, m, a, n, n, ;, , M, a, u, r, e, e, n, , D, r, e, h, e, r, ;, , A, n, d, r, e, w, , F, a, r, b, ;, , M, i, c, h, a, e, l, , H, o, f, f, m, a, n, n, ;, , C, h, r, i, s, t, o, p, h, e, r, , M, , L, o, f, t, u, s, ;, , N, i, n, a, , M, e, z, u, -, N, w, a, b, a, ;, , V, i, v, e, k, , P, i, n, t, o, ;, , X, i, a, o, l, i, n, , Z, h, e, n, g, ;, , C, a, r, l, o, s, , P, e, ñ, a

RevistaJournal of neurosurgery
Año
PMID34087794

Resumen

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start n

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.

↑