FORM P. Use of Any Device Being Tested in Research
Complete "Form P" and include with your application submission if your research involves evaluating the safety or effectiveness of a device in subjects, controls, or their specimens or clinical or investigational use of a Humanitarian Use Device (HUD).
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 [HTML]. 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 Section A on "Form P", indicate if the intended use involves a 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 4,000 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 - Humanitarian Use Devices (21 CFR Parts 20 and 814 Subpart H) [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 more information about Clinical Engineering policy go to http://www.mc.uky.edu/clinicalengineering/, or for assistance or to request inspection/authorization from Clinical Engineering, call 859-323-6383.