> ## Content Index
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# Guide on BPH Device Clinical Trials
- URL: https://www.fdaweb.com/guide-on-bph-device-clinical-trials/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147177

FDA has made available a [draft guidance ](https://www.fda.gov/media/139952/download?ref=fdaweb.com)on “Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” The document proposes the addition of several BPH treatment devices to a [2010 final guidance](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=2020-07-13%20Draft%20Guidance%20BPH%20Device%20Update&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=14186&elqTrackId=C55F54425AF43FCF5AD10AE23730C524&elq=f1d3d5c1f0d24197990d19aedf91de97&elqaid=13310&elqat=1) of the same name. Additionally, it updates several non-clinical and clinical testing recommendations to better align with the agency’s current thinking on the topics and to incorporate study design best practices.