Evaluating New Ophthalmic Digital Devices for Safety and Effectiveness in the Context of Rapid Technological Development.
PMID: 31169870 ·
Z, a, c, h, a, r, y, , M, , B, o, d, n, a, r, ;, , R, o, n, a, l, d, , S, c, h, u, c, h, a, r, d, ;, , D, a, v, i, d, , M, y, u, n, g, ;, , M, i, c, h, e, l, l, e, , E, , T, a, r, v, e, r, ;, , M, a, r, k, , S, , B, l, u, m, e, n, k, r, a, n, z, ;, , N, a, t, a, l, i, e, , A, , A, f, s, h, a, r, i, ;, , M, a, r, k, , S, , H, u, m, a, y, u, n, ;, , C, h, r, i, s, t, i, e, , M, o, r, s, e, ;, , K, e, n, , N, i, s, c, h, a, l, ;, , M, i, c, h, a, e, l, , X, , R, e, p, k, a, ;, , D, e, r, e, k, , S, p, r, u, n, g, e, r, ;, , M, i, c, h, a, e, l, , T, r, e, s, e, ;, , M, a, l, v, i, n, a, , B, , E, y, d, e, l, m, a, n
Publicidad
Resumen
The US Food and Drug Administration's medical device regulatory pathway was initially conceived with hardware devices in mind. The emerging market for ophthalmic digital devices necessitates an evolution of this paradigm. To facilitate innovation in ophthalmic digital health with attention to safety and effectiveness. This article presents a summary of the presentations, discussions, and literature review that occurred during a joint Ophthalmic Digital Health workshop of the American Academy of
Publicidad
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.