Question

Which of the following are included with an investigational device exemption (IDE) submission to the U.S. Food and Drug Administration (FDA)?

1) Clinical data
2) Investigator brochure
3) Protocol
4) Informed consent form

Answer 1

An Investigational Device Exemption (IDE) submission to the FDA includes clinical data, an investigator brochure, a protocol, and an informed consent form. These components ensure participant safety and informed participation in clinical trials for medical devices.

Step-by-step explanation:

The components included with an Investigational Device Exemption (IDE) submission to the U.S. Food and Drug Administration (FDA) are essential for ensuring that clinical trials for medical devices are conducted safely and ethically. An IDE application typically includes:

• Clinical data
• Investigator brochure
• Protocol
• Informed consent form

The investigator brochure contains a compilation of the clinical and nonclinical data on the investigational device that is relevant to the study of the device. The protocol outlines the methodology to be followed in the clinical trial. It is important that an informed consent form is included, as participants must be fully aware of the study's scope and potential risks, and agree to participate voluntarily. Submission of these documents helps to assure the FDA that the rights, safety, and welfare of trial participants will be protected.