Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Pediatric Product Development, Premarket
Published
July 11, 2019
Last updated
April 11, 2024
Description
This document provides guidance on live case presentations during IDE clinical trials, covering GCP, IDE, and premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)