Clinical Investigations for Prostate Tissue Ablation Devices | FDA

Clinical Investigations for Prostate Tissue Ablation Devices | FDA

FDA Issues Final Guidance on Clinical Investigations for Prostate Tissue Ablation Devices

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance: Clinical Investigations for Prostate Tissue Ablation Devices. This final guidance document provides recommendations for: Complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation. Collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices, whether by high intensity ultrasound or alternative technologies. Before manufacturers start a clinical investigation for prostate tissue ablation devices, the FDA encourages them to submit a Pre-Submission to get detailed feedback on the clinical investigation planned.

Read the Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.