Orbital Implants Receiving Food and Drug Administration Premarket Notification.
PMID: 35699217 ·
K, i, a, r, a, , M, , C, o, r, c, o, r, a, n, , R, u, i, z, ;, , Y, a, s, h, , J, , V, a, i, s, h, n, a, v, ;, , J, o, r, d, a, n, , D, e, s, a, u, t, e, l, s, ;, , J, a, m, i, e, , L, , S, c, h, a, e, f, e, r, ;, , M, i, c, h, a, e, l, , E, , M, i, g, l, i, o, r, i, ;, , T, a, y, g, a, n, , Y, i, l, m, a, z
Реклама
Аннотация
This perspective explores the Food and Drug Administration (FDA) 510(k) program, occasionally referred to as premarket notification, which facilitates faster marketing of Class II medical devices, such as orbital implants by demonstrating "substantial equivalence" to previously approved devices. This allows for FDA clearance, rather than FDA approval of orbital implants via comparison to currently marketed implants rather than clinically proven safety standards. Utilizing the FDA's publicly avai
Реклама
Официальный источник
Открыть в PubMed →Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.