Making Prostate Ablation Devices Safer

FDA has ramped up medical device safety efforts in several areas this year. Most recently, the agency has turned its attention to devices designed to ablate prostate tissue. The agency issued draft guidance Tuesday to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high-intensity ultrasound systems for prostate tissue ablation devices regulated under the agency’s 510(k) premarket notification program. This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or forms of energy to ablate (or destroy) prostate tissue. “Devices that ablate or destroy prostate tissue require important safety and effectiveness data prior to marketing. As part of our continued commitment to aggressively addressing device safety while also encouraging innovation to provide patients with the safest and most effective treatment options, today we are providing recommendations on the type of clinical data manufacturers should include in their marketing submissions for prostate tissue ablation devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Our proposal highlights the use of clinical evidence under the 510(k) premarket notification p...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news