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

Issue Date: December 27, 2021
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Gastroenterology-Urology , Good Clinical Practice (GCP)
Status: Final

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

This guidance document provides the FDA’s recommendations on non-clinical and clinical investigational plans to support premarket submissions for devices used in the treatment of benign prostatic hyperplasia (BPH). This guidance only applies to devices that are indicated for the treatment of BPH. The recommendations are intended to promote consistency and facilitate efficient review of premarket submissions for these devices.

Download the Guidance Document