Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.
PMID : 28291189 ·
B, r, i, a, n, , W, , Y, a, n, g, ;, , M, a, t, t, h, e, w, , L, , I, o, r, i, o, ;, , C, h, a, r, l, e, s, , S, , D, a, y
Publicité
Résumé
The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however,
Publicité
Source officielle
Voir sur PubMed →Données issues de PubMed / NCBI. Pour le texte intégral et les informations les plus récentes, consultez toujours la notice officielle.