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
Anzeige
Zusammenfassung
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
Anzeige
Offizielle Quelle
Auf PubMed ansehen →Daten aus PubMed / NCBI. Den Volltext und die aktuellsten Informationen finden Sie stets im offiziellen Eintrag.