IDE — Investigational Device Exemption
The IDE framework is a US-specific regulatory mechanism. Conducting a clinical investigation of an unapproved device in the USA without an IDE (when required) is a violation of the FD&C Act.
What is an IDE?
An Investigational Device Exemption (IDE) permits an investigational device — one that has not been cleared or approved by FDA — to be used in a clinical study in the United States. The IDE exempts the investigational device from many of the FD&C Act's requirements so that the study can be conducted.
Regulated under 21 CFR Part 812.
When is an IDE required?
An IDE is required when a clinical investigation involves a significant risk (SR) device — a device that presents a potential for serious risk to the health, safety, or welfare of a subject.
An IDE is not required (but IRB approval is still needed) for:
- Non-significant risk (NSR) device studies
- Studies of devices that are already cleared/approved and used according to their cleared/approved labelling (no IDE needed for standard of care use)
- Certain exempt investigations under 21 CFR § 812.2(c)
SR vs NSR determination
The sponsor and IRB make the initial determination of SR vs NSR. FDA may disagree and require an IDE.
| SR devices | NSR devices |
|---|---|
| Implants intended to be used for >30 days | External devices for short-term use |
| Devices supporting/sustaining life | Devices for non-serious conditions |
| Devices of substantial importance to health | Low-risk diagnostic devices |
| Devices presenting serious injury risk | Devices similar to already-cleared predicates |
IDE application contents
An IDE application to FDA must include:
- Report of prior investigations (non-clinical and clinical)
- Investigational plan (protocol)
- Description of device and manufacturing
- Investigator information
- IRB approvals (or information on IRB review)
- Informed consent procedures
- Financial disclosure information (21 CFR Part 54)
FDA review goal: 30 days for IDE application.