Investigational Device Exemption (IDE):

An investigational device exemption (IDE) allows an 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. Title 21 Code of Federal Regulations Part 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports. Additional information regarding IDEs can be found at http://www.fda.gov/cdrh/devadvice/ide/index.shtml or by calling the IDE Staff at (301) 594-1190.