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IRB Application: Additional Study Materials

Section 4
FORM P.  Use of Any Medical Device Being Tested in Research

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Instructions/Guidance

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 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 more information go to the Clinical Engineering web page, or for assistance or to request inspection/authorization from Clinical Engineering, call 859-323-8586.

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Definitions

Medical Device
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body …. and which is not dependent upon being metabolized for the achievement of its primary intended purposes (Federal Food, Drug, and Cosmetic Act).

Significant Risk device study is defined [21 CFR 812.3(m)] as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. Note: A significant risk device study requires an Investigational Device Exemption (IDE) be approved by FDA.

Nonsignificant Risk device investigation is one that does not meet the definition for a significant risk study.

Humanitarian Use Device (HUD) [21 CFR 814]
A HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year. The statute and the implementing regulation (see 21 CFR 814.124(a)) require IRB review and approval before a HUD is used. For use of a HUD in clinical, emergency, compassionate, and investigation situations refer to the "Humanitarian Use Device SOP" [PDF] and the "IRB Summary Medical Devices: Humanitarian Use Devices" document [PDF]. For more information on HUDs and Humanitarian Device Exemptions (HDE) Regulations see the FDA HDE Regulation Question and Answers guidance.

Treatment Investigational New Device Exemption [21 CFR 812.36]
A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available. During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial under the provisions of a Treatment IDE.

For additional definitions, see the UK IRB/ORI Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE SOP [PDF]

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