Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.
PMID：42324971 ·
H, e, l, e, n, , B, a, n, k, s, ;, , M, a, r, i, a, , L, u, i, s, a, , B, u, z, e, l, l, i, ;, , O, r, n, e, l, l, a, , T, a, n, g, i, l, a, , K, a, y, e, m, b, e, ;, , N, i, c, o, l, a, s, , M, a, r, t, e, l, l, i, ;, , M, a, j, e, l, l, a, , G, e, r, a, g, h, t, y, ;, , G, i, u, d, i, t, t, a, , C, a, l, l, e, a
廣告
摘要
Early Feasibility Studies (EFS) enable limited early-stage clinical evaluation of novel medical devices when non-clinical testing is insufficient to inform design, safety, or performance. While the US Food and Drug Administration has an established EFS program, the EU lacks a dedicated framework, creating uncertainty for innovators and regulators. This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed,
廣告
官方來源
在 PubMed 上查看 →資料來自 PubMed / NCBI。全文與最新資訊請一律參閱官方紀錄。