Humanitarian Use Device (HUD) Designations : 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 5, 2019
Last updated
May 13, 2021
Description
This document is a guidance for industry and FDA staff on Humanitarian Use Device (HUD) Designations, covering topics like Good Clinical Practice and Premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)