ABSTRACT
The Medical Device Amendment of 1976, and its updated 1990 version, requires approval from the Food and Drug Administration (FDA) before new devices are marketed and imposes requirements for the clinical investigation of new medical devices on human subjects. Although the statute makes interstate commerce of an unapproved new medical device generally unlawful, it provides an exception to allow interstate distribution of unapproved devices in order to conduct clinical research on human subjects. This investigational device exemption (IDE) can be obtained by submitting to the FDA “a protocol for the proposed clinical testing of the device, reports of prior investigations of the device, certification that the study has been approved by a local institutional review board, and an assurance that informed consent ’will be obtained from each human subject”[Bronzino et al., 1990a,b; 1992; 1995; 1999; 2000].
