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.”
Purpose of an IDE 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 have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for 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.
Our qualified team of experts will successfully prepare and submit FDA medical device regulatory well-researched documentation to support your IDE Process application. We will also help to schedule a meeting to help you get answers to all your questions on medical device development.
To learn more about Pre-IDE process, contact us today