- Definitions
- IRB Application Requirements
- Making the Significant vs. Non-significant Risk Determination
Definitions
FDA regulations state that for studies involving use of an investigational device, the investigator (or sponsor) must obtain either a "significant risk" Investigational Device Exemption (IDE) from the FDA, or a determination of "non-significant risk" from the IRB.
The FDA's "Significant Risk and Nonsignificant Risk Medical Device Studies" Information Sheet provides criteria for the investigator and IRB to use in making these decisions. Also see the UCSF Investigator Checklist for IDE Exempt, Non-Significant, and Significant Risk Device Studies for a quick overview of when an IDE from the FDA is required or not required.
Significant risk (SR) device |
21 CFR 812.3 defines a SR device as an investigational device that:
Examples: Artificial skin and interactive wound and burn dressings, intravascular stents, bronchial tubes. See the FDA info sheet for more examples. |
Non-significant risk (NSR) device |
A NSR device is one that does not meet the definition of a SR device. Examples: Low-power lasers for treatment of pain and daily-wear contact lenses. See the FDA info sheet for more examples. |
IRB Application Requirements
If the investigator or sponsor believes a device poses non-significant risk, complete the "Non-Significant Risk Determination for an Investigational Device" section in the IRB Application.
Additional supporting information should be submitted, as appropriate — see the IRB submission info on the Investigational Devices page for more details. The IRB should also be informed if the FDA or any other IRB has determined the device to present SR or NSR, and provide any further information requested by the IRB.
Making the Significant vs. Non-significant Risk Determination
The IRB must make two separate decisions, based on different criteria.
1. Is the investigation approvable or not? — The criteria for deciding if a study involving either a SR or NSR device can be approved are the same as those used to evaluate any proposed research project.
2. Does the device present SR or NSR? — The IRB review criteria and review process are described below.
IRB's Criteria for Determining SR vs. NSR
SR vs. NSR Determination
The IRB may agree or disagree with the investigator's or sponsor's initial NSR assessment. If the IRB agrees with the NSR determination, the investigation may proceed without FDA approval after the IRB approves the study.