1. 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 Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021 Subject(s): Device ApprovalProstatic Hyperplasia -- therapyUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration