Eckert S E
Department of Dental Specialties, Mayo Clinic, Rochester, Minn, USA.
J Prosthet Dent. 1995 Aug;74(2):162-8. doi: 10.1016/s0022-3913(05)80180-5.
The Food and Drug Administration (FDA) is a section of the Department of Health and Human Services of the United States Government, and its primary responsibility is to control the distribution of food, drugs, and medical devices within the country while ensuring public safety. The sale and distribution of dental implants is under the regulatory control of the FDA. Device classification, procedures for approval, and the current status of the approval process for endosseous implants are described in this article. The premarket approval procedure of the FDA is compared with the American Dental Association certification process. Issues related to the safety and effectiveness of dental implants are discussed.
美国食品药品监督管理局（FDA）是美国政府卫生与公众服务部的一个部门，其主要职责是在确保公众安全的同时，控制国内食品、药品和医疗器械的分销。牙科植入物的销售和分销受FDA的监管。本文介绍了器械分类、审批程序以及骨内植入物的审批流程现状。将FDA的上市前审批程序与美国牙科协会的认证程序进行了比较。讨论了与牙科植入物安全性和有效性相关的问题。
