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The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act provide for the classification of a medical device intended for human use into one of three regulatory classes based on the extent of control necessary to ensure safety and effectiveness: Class I, General Controls; Class II, Performance Standards; Class III, Premarket Approval. Class III devices are those for which there is insufficient information available to ensure safety and effectiveness through General Controls and Performance Standards alone. New devices such as Nuclear Magnetic Resonance Imaging systems fall under Class III because they were developed after the date of the law's enactment (28 May 1976). Investigational studies involving human subjects undertaken to develop safety and effectiveness data for a post-enactment Class III device come under the Investigational Device Exemption (IDE) Regulation (21 CFR 812). This regulation distinguishes between investigations of devices that pose a significant risk to the human subject and those that do not. A significant risk investigation "presents a potential for serious risk to the health, safety, or welfare of a subject." Procedures for obtaining an IDE differ if the device does or does not pose a significant risk. The sponsor of a clinical trial, and ultimately the Institutional Review Board (IRB), have the primary responsibility to determine whether a certain clinical use of the investigational device represents a significant risk to the subject of the investigation. A finding of significant risk does not mean that a device is too hazardous for clinical studies, but it does mean that a formal application for an IDE must be made to and approved by the Food and Drug Administration (FDA) before a clinical trial can begin. If the device is deemed not to pose a significant risk, unless otherwise notified by FDA, the sponsor is not required to submit an IDE application to FDA. Instead, the sponsor and investigators must satisfy only certain abbreviated requirements including maintenance of certain records and reports. In addition, the sponsors must maintain IRB approval throughout the investigation, label the device in accordance with the IDE regulation, and ensure that the investigators obtain and document informed consent for each subject under their care.
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