The Center for Devices and Radiological Health (CDRH) of the FDA, issued a 10-page drafted clinical recommendations to support and approve clinical test for a high-intensity ultrasound concerning prostate tissue ablation devices. The recommendation focuses on clinical investigations for the ablation devices and decisions that will affect the premarket regulatory decisions such as benefit risks and intended use of the device.

 The CDRH guidance only focuses on the clinical investigation concerning only the general indications for Prosthetic Tissue Ablation Systems and not the investigation concerning the disease treatments. The investigated data must be sufficient to acknowledge the ablation of the intended tissue region to support market authorization.