This guidance identifies the key features of non‐clinical and clinical investigational plans used to support investigational device exemptions (IDEs), premarket approval applications (PMAs), and some premarket notifications (510(k)s) for devices used in the treatment of BPH. Some recommendations in this document 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. We encourage you to contact the Urology and Lithotripsy Devices Branch (ULDB) when designing your clinical investigation and prior to submission of an original IDE application.