PubMed

分析FDA批准的骨科設備及其召回情況

PMID：26984921 · 2016-03-16

C, h, a, r, l, e, s, , S, , D, a, y, ;, , D, a, v, i, d, , J, , P, a, r, k, ;, , F, r, e, d, e, r, i, c, k, , S, , R, o, z, e, n, s, h, t, e, y, n, ;, , N, a, n, a, , O, w, u, s, u, -, S, a, r, p, o, n, g, ;, , A, l, d, e, b, a, r, a, n, i, , G, o, n, z, a, l, e, z

期刊The Journal of bone and joint surgery. American volume

年份2016-03-16

PMID26984921

摘要

The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled. Using the FDA's public da

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。