Benign Prostatic Hyperplasia Device Guidance

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 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.