FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
August 19, 2014
Last updated
April 26, 2021
Description
This is a guidance document by the FDA for sponsors, investigators, and review boards on IDE clinical investigations and premarket devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)