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GUIDANCE DOCUMENT

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 December 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1118
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1118.

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