Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Premarket
Published
July 15, 2020
Last updated
July 14, 2020
Description
This is a guidance document for clinical investigations of prostate tissue ablation devices, covering topics like GCP, IDE, and premarket requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)