Pre-IDE Process

An IDE is a regulatory submission that permits clinical investigation of devices. This investigation is exempt from some regulatory requirements. The name “Investigational Device Exemption” stems from this description in 21 CFR 812.1:

“An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.”

The purpose of an IDE is to encourage discovery and development of useful medical devices for human use, to the extent consistent with the protection of the public health and safety and with ethical standards, while maintaining optimum freedom for scientific investigators in their pursuit of that purpose.

FDA encourages medical device manufacturers to obtain further guidance before the submission of an IDE application. This will be especially beneficial to new sponsors who had no previous contact with the agency or for sponsors proposing to study new technologies or for new uses of existing technologies. Early interaction with the agency should help to increase the sponsor’s understanding of FDA requirements, regulations, and guidance documents. It will allow FDA personnel to familiarize themselves with the new technologies.