IRB Application Instructions: Study Device

Use of Any Medical Device Being Tested in Research

Instructions/Guidance

If your study involves testing (collecting safety or efficacy data) of a medical device including an FDA approved device, unapproved use of an approved device, humanitarian use device, and/or an investigational device, answer "yes" to the question at the top of the Study Device Information section of your E-IRB application and complete the questions as prompted and upload the required Study Device Form (PDF).

The IRB must assess the risk/benefit ratio, determine whether the device is a "significant risk device", confirm that the device has appropriate regulatory approval (or meets exemptions for such approval), and ensure that procedures for receiving, storing, dispensing, and accountability meet regulatory requirements and are appropriate for human subject protections.

Under Food and Drug Administration (FDA) regulations, research that involves a significant risk device must be conducted under an FDA approved Investigational Device Exemption (IDE), unless the study meets one of the exemptions from the IDE requirement [21 CFR 812.2(c)].

It is the sponsor's (or sponsor-investigator's) responsibility to make a preliminary determination regarding whether a device meets the definition of significant risk and if an IDE is needed. For guidance, see FDA's decision document for IDE Investigations (PDF). The principal investigator (PI) is responsible for consulting the sponsor, FDA guidance, or checking with FDA to document appropriate regulatory approval.

For assistance in making a significant risk (SR) and nonsignificant risk (NSR) determinations, contact FDA or visit the FDA web pages FDA Device Advice and FDA's Information Sheets on Medical Devices, or download "FDA's Information Sheet Guidance regarding significant risk and non-significant risk medical device studies" (PDF) and/or "FDA's Frequently Asked Questions About Medical Devices (PDF).

The IRB must also ensure investigators who assume the role of sponsor for SR or NSR device studies are knowledgeable about additional regulatory and institutional requirements. If you are functioning as the PI and sponsor for an FDA regulated device study, IRB policy requires that you complete the UK IRB Sponsor Investigator Mandatory Training or equivalent sponsor education program. For an overview of the FDA requirements for device study sponsor investigators, see ORI's document: Summary Of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices (PDF). For information and instructions on sponsor-investigator training, see ORI's document: University of Kentucky Sponsor-Investigator Mandatory Training (PDF).

In completing the Study Device Form (PDF), indicate if the intended use involves an FDA Approved Humanitarian Use Device (HUD). This is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 8,000 individuals in the United States per year. To obtain FDA approval for a HUD, a humanitarian device exemption (HDE) application is submitted to FDA. When a HUD is used in clinical practice, the federal regulations require IRB review and approval before a HUD is used. The healthcare provider is responsible for obtaining IRB approval before he or she uses a HUD to treat or diagnose patients. Refer to the HUD section of the FDA's Frequently Asked Questions About Medical Devices for guidance, and ORI's "IRB Summary Medical Devices: Humanitarian Use Devices" document (PDF).

If you are proposing use of a device which requires electrical connection (i.e., plug-in to wall outlet) within the UK Hospital, please be aware that the device should be inspected and authorized for use by a Department of Clinical Engineering representative. Inspection/authorization from Clinical Engineering is optional for device research conducted in the KY Clinic. For assistance or to request inspection/authorization from Clinical Engineering, call the UK Healthcare Service Desk line (859-323-8586) to submit a work order for your request.

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