Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation. Final order.

Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation. Final order.
Fed Regist. 2017 Oct 02;82(189):45725-7
Authors: Food and Drug Administration, HHS
Abstract
The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for
prostate tissue ablation’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative
devices, in part by reducing regulatory burdens.
PMID: 28990746 [PubMed - in process]

Source: Fed Regist - October 2, 2017 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research