Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
December 27, 2021
Last updated
December 23, 2021
Description
This document is a guidance for industry and FDA staff on the investigation of devices used for the treatment of Benign Prostatic Hyperplasia (BPH).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)