RESOURCES

» FDA CDRH (Center for Devices & Radiological Health)

FDA homepage for the Center for Devices & Radiological Health.

» FDA IDE (Investigational Device Exemption)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.

» FDA IRB (Investigational Review Boards)

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.