Investigational Device Exemption (IDE)

An investigational device exemption (IDE) allows a new medical device to be used in a clinical study to collect data on its safety and effectiveness. This exemption is necessary for the device to be tested in humans before it can be approved for general use. The IDE must be approved by the FDA before initiating any clinical evaluation of the device, unless the device is exempt from IDE requirements.

Devices that typically require an IDE include:

• Instruments: Tools used for diagnostic or therapeutic purposes
• Machines: Devices that perform specific functions related to health care
• Implants: Devices inserted into the body to treat or manage health conditions
• In vitro reagents: Substances used to test or measure biological samples outside the body
• Implements: Devices that aid in the treatment or diagnosis of diseases or conditions

The device must be intended to:

• Diagnose, mitigate, cure, treat, or prevent a disease or other condition
• Affect the structure or function of the body
• Operate through mechanical or physical means, rather than through chemical action or metabolism

Types of IDEs include:

1. FDA Oversight IDE: For devices that pose a significant risk (S.R.) to patients. These devices require more stringent oversight and approval processes.
2. Abbreviated IDE: For devices that pose a non-significant risk. The regulatory requirements are less rigorous compared to those for significant risk devices.