Pritchard W F, Abel D B, Karanian J W
Hydrodynamics and Acoustics Branch, Division of Physical Sciences, Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
J Vasc Interv Radiol. 1999 Feb;10(2 Pt 1):115-22. doi: 10.1016/s1051-0443(99)70452-5.
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." 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 approval 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 approval process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed.
确定医疗器械安全性和有效性的临床研究受研究器械豁免（IDE）法规管辖。IDE法规的目的是“在符合保护公众健康和安全以及伦理标准的前提下，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者追求此目标时保持最佳的自由”。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研发期间以及准备IDE申请期间，通过IDE预批准程序与该机构进行早期互动。这有助于IDE申请的获批并推进到临床研究阶段。本文回顾了IDE法规的术语、适用性以及需要向美国食品药品监督管理局提交IDE申请的研究类型。还讨论了IDE预批准程序以及用于心血管器械重大风险研究的IDE申请的制定。
