Regulatory review/Investigational Device Exemption
An investigational device exemption (IDE) (21CFR 812) 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. All aspects of the IDE process are described by the FDA.
- Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
- Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages