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# Benign Prostatic Hyperplasia Device Guidance
- URL: https://www.fdaweb.com/benign-prostatic-hyperplasia-device-guidance/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150811

FDA has published a guidance, *Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)*, to identify the key features of non-clinical and clinical investigation plans used to support IDE applications, PMAs, de novo classification requests, and some 510(k) submissions for devices used in treating BPH. The document [says](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-and-clinical-investigation-devices-used-treatment-benign-prostatic-hyperplasia-bph?ref=fdaweb.com) some of its recommendations may not apply to a particular device, and additional recommendations may be appropriate for novel device types or technologies.

“FDA will consider alternative non-clinical and clinical testing when the proposed alternatives are supported by an adequate scientific rationale,” the guidance says.

Included in the document are Introduction, Scope, Non-Clinical Testing Recommendations, Pilot Clinical Study Recommendations, Pivotal Clinical Study Recommendations, Conclusions, and an Appendix.