FDA Issues Draft Guidance on Clinical Investigations for Prostate Tissue Ablation Devices

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance: Clinical Investigations for Prostate Tissue Ablation Devices. This draft guidance document provides recommendations for: Complying with the clinical testing special control under 21 CFR 876.4340 for premarket notifications (510(k)s) for high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Read the Draft Guidance Submit comments on this draft guidance This draft guidance will be open for public comments for 60 days, until August 26, 2019, atwww.regulations.gov under docket number FDA-2019-D-2223.