Pritchard W F, Abel D B, Karanian J W
Hydrodynamics and Acoustics Branch, Division of Physical Sciences, Office of Science and Technology, Rockville, MD, USA.
J Vasc Surg. 1999 Mar;29(3):566-74. doi: 10.1016/s0741-5214(99)70288-0.
The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed.
用于确定医疗器械安全性和有效性的临床研究受研究性器械豁免（IDE）法规的管辖。IDE法规的目的是“在与保护公众健康和安全以及伦理标准相一致的范围内，鼓励发现和开发供人类使用的有用器械，并为此目的在科学研究人员追求这一目标时保持最大程度的自由”（《联邦食品、药品和化妆品法案》）。开展临床研究可能需要一份获批的IDE申请。美国食品药品监督管理局鼓励在器械或技术的研发过程以及IDE申请的准备过程中，通过IDE前程序与该机构进行早期互动。这有助于IDE申请的获批以及进入临床研究阶段。本文回顾了IDE法规的术语、适用性以及需要向食品药品监督管理局提交IDE申请的研究类型。还讨论了IDE前程序以及心血管器械重大风险研究的IDE申请的制定。
