PubMed

Evaluating New Ophthalmic Digital Devices for Safety and Effectiveness in the Context of Rapid Technological Development.

PMID: 31169870 · 2019-08-01

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

ЖурналJAMA ophthalmology

Год2019-08-01

PMID31169870

Аннотация

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

Официальный источник

Открыть в PubMed →

Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.