Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
September 6, 2019
Last updated
September 5, 2019
Description
This document is a guidance for the Humanitarian Device Exemption (HDE) Program, providing information for industry and FDA staff on Good Clinical Practice (GCP) and Premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)