A medical device is defined, in part, as any health care product that does not achieve its primary intended purpose by chemical action or by being metabolized. Examples of medical devices include, but are not limited to, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts or stents, intraocular lenses, orthopedic pins, and radiographic imaging equipment. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis of disease or other medical conditions such as pregnancy.
For research involving medical devices, the UOP IRB will comply with the requirements set forth in 21 CFR Part 812. These regulations describe two types of investigational device studies, "significant risk" and "non-significant risk."
- A "significant risk device study" is defined by FDA regulations as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and/or a) is intended as an implant (An “implant” is defined by the FDA as “a device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more”. The FDA may determine that devices placed into human subjects for shorter periods of time are also implants.); b) is used in supporting or sustaining human life; c) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of human health or d) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
- A "non-significant risk device study" is a study of a device that does not meet the FDA’s definition for a "significant risk device study."
The determination that a device study presents a “significant risk” or a “non-significant risk” is initially made by the sponsor/investigator. If the sponsor/investigator considers the device study to be of “non-significant risk”, the sponsor/investigator must provide the IRB with an explanation of this determination and copies of the respective research protocol and informed consent document. The sponsor should inform the IRB of the FDA’s assessment of the risk status of the proposed device study, if such an assessment has been made. The IRB may question whether other IRBs have reviewed the proposed device study and what determination they made or the IRB may consult with the FDA for its opinion.
In making the risk determination, the IRB considers both the device as well as the nature of harm that may result from the use of the device. The IRB may agree or disagree with the determination of the sponsor/investigator.
If the IRB determines that the device study presents “non-significant risk”, and approves the research study and informed consent document(s), the study may proceed without further notification of the FDA.
If the IRB determines that the device study presents a “significant risk”, the sponsor must notify the FDA that the device study has been determined to be of “significant risk” and if electing to proceed with the study, must submit an IDE application. The device study may not commence until the FDA approves the IDE and the IRB approves the device risk designation, the study protocol and informed consent document(s).
The IRB will utilize the device checklist in making this determination and the determination will be recorded in the IRB meeting minutes.