Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Premarket
Published
July 27, 2016
Last updated
October 20, 2020
Description
This document is a guidance for industry and FDA staff on adaptive designs for medical device clinical studies, covering topics like GCP, IDE, and premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)