Food Labeling Compliance Seminar – September 24-25, 2018 in Kansas City, MO

Specializing in FDA Regulatory Matters

Investigational Device Exemption (IDE)

Under 21CFR Part 812, 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. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin.