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An investigational device is a medical device which is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. Clinical investigations undertaken to develop safety and effectiveness data for medical devices must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulations. An IDE study may not necessarily commence 30 days after an IDE submission to FDA. Certain clinical investigations of devices (e.g., certain studies of lawfully marketed devices) may be exempt from the IDE regulations.
If the sponsor has an IDE number or the IRB requires an IDE, the investigator must submit to the IRB documentation of the assignment of an IDE number using the HawkIRB system. If the IDE is an investigator held IDE, the entire IDE application is required. This documentation must be attached to the new project application in HawkIRB. IRB staff will check for this documentation and return protocols with inadequate or incomplete documentation of the IDE.
Significant and Nonsignificant Risk Medical Device Studies
The Investigational Device Exemption (IDE) regulations describe two types of device studies, "significant risk" (SR) and "nonsignificant risk" (NSR). An SR device study is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and:
- is intended as an implant; or
- is used in supporting or sustaining human life; or
- is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or
- otherwise presents a potential for serious risk to the health, safety, or welfare of a subject
An NSR device investigation is one that does not meet the definition for a significant risk study. NSR device studies, however, should not be confused with the concept of "minimal risk," a term utilized in the regulations [21 CFR part 56] to identify certain studies that may be approved through an "expedited review" procedure. For both SR and NSR device studies, IRB approval prior to conducting clinical trials and continuing review by the IRB are required. In addition, informed consent must be obtained for either type of study [21 CFR part 50].
Unless exempt from the IDE regulations, an investigational device must be categorized as either "significant risk" (SR) or "nonsignificant risk" (NSR). The determination that a device presents a nonsignificant or significant risk is initially made by the sponsor. The proposed study is then submitted either to FDA (for SR studies) or to an IRB (for NSR studies).
SR device studies must be conducted in accordance with the full IDE requirements, and may not commence until 30 days following the sponsor's submission of an IDE application to FDA. Submission of the IDE application enables FDA to review information about the technical characteristics of the device, the results of any prior studies (laboratory, animal and human) involving the device, and the proposed study protocol and consent documents. Based upon the review of this information, FDA may impose restrictions on the study to ensure that risks to subjects are minimized and do not outweigh the anticipated benefits to the subjects and the importance of the knowledge to be gained. The study may not commence until FDA has approved the IDE application and the IRB has approved the study.
In contrast, NSR device studies do not require submission of an IDE application to FDA. Instead, the sponsor is required to conduct the study in accordance with the "abbreviated requirements" of the IDE regulations. Unless otherwise notified by FDA, an NSR study is considered to have an approved IDE if the sponsor fulfills the abbreviated requirements. The abbreviated requirements address, among other things, the requirements for IRB approval and informed consent, recordkeeping, labeling, promotion, and study monitoring. NSR studies may commence immediately following IRB approval.
Once the final SR/NSR decision has been rendered by the IRB (or FDA), the IRB must consider whether the study should be approved. In considering whether a study should be approved, the IRB should use the same criteria it would use in considering approval of any research involving an FDA regulated product (21 CFR 56.111). FDA considers all SR studies to present more than minimal risk, and thus, full IRB review is necessary. In making its determination on approval, the IRB should consider the risks and benefits of the medical device compared to the risks and benefits of alternative devices or procedures.
Distinguishing between SR and NSR Device Studies (21 CFR part 812)
SR device studies are governed by the IDE regulations. NSR device studies have fewer regulatory controls than SR studies and are governed by the abbreviated requirements. The major differences are in the approval process and in the record keeping and reporting requirements. The SR/NSR decision is also important to FDA because the IRB serves, in a sense, as the Agency's surrogate with respect to review and approval of NSR studies. FDA is usually not apprised of the existence of approved NSR studies because sponsors and IRBs are not required to report NSR device study approvals to FDA. If an investigator or a sponsor proposes the initiation of a claimed NSR investigation to an IRB, and if the IRB agrees that the device study is NSR and approves the study, the investigation may begin at that institution immediately, without submission of an IDE application to FDA.
If an IRB believes that a device study is SR, the investigation may not begin until both the IRB and FDA approve the investigation. To help in the determination of the risk status of the device, IRBs should review information such as reports of prior investigations conducted with the device, the proposed investigational plan, a description of subject selection criteria, and monitoring procedures. The sponsor should provide the IRB with a risk assessment and the rationale used in making its risk determination.