Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
PMID: 39374526 ·
K, u, s, h, a, l, , T, , K, a, d, a, k, i, a, ;, , V, i, n, a, y, , K, , R, a, t, h, i, ;, , S, a, n, k, e, t, , S, , D, h, r, u, v, a, ;, , J, o, s, e, p, h, , S, , R, o, s, s, ;, , H, a, r, l, a, n, , M, , K, r, u, m, h, o, l, z
Publicidade
Resumo
Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) c
Publicidade
Fonte oficial
Ver no PubMed →Dados provenientes do PubMed / NCBI. Para consultar o texto integral e as informações mais recentes, recorra sempre ao registo oficial.