Tylenda C A
Division of Dental Infection Control and General Hospital Devices, US Food and Drug Administration, Rockville, MD 20895, USA.
Technol Health Care. 1996 Sep;4(3):259-67.
Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.
在过去几年中，美国食品药品监督管理局（FDA）的器械评估与研究中心（CDRH）每年收到超过1.6万份与医疗器械相关的申报材料。其中超过1万份是主要申报材料，包括进行临床试验的申请以及为特定使用适应症销售医疗器械的申请。每份申请都经过仔细审议。FDA工作人员与申请人密切合作，以确保临床试验设计将对患者的风险降至最低，并在解决受试器械的安全性和有效性方面使益处最大化。必要时，会给予申请人一切机会提供额外信息，以确保医疗器械上市申请的完整性。在申请并非简单直接的情况下，申请人有机会在提交申请前与FDA工作人员会面。此外，FDA通过制定指导文件来协助申请人，这些文件讨论了在申报材料中包含哪些有益信息。FDA的小型制造商援助部门致力于帮助相关人士了解审批流程。本文将讨论FDA在医疗器械监管中的作用，重点是在美国获得医疗器械上市许可的途径。
