June 25, 2019
“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, M.D., J.D., 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 program. This guidance also advances both safety and innovation by clarifying the clinical evidence that would support new and safe ways to destroy prostate tissue such as ultrasound or alternative technologies. By doing so, we can help give patients access to safer, more effective devices than they had even a few years ago.”
Today, the FDA issued a draft guidance to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high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 This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or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.
For these types of prostate ablation devices, the FDA requires clinical testing to show that each new device addresses patient safety by demonstrating that the device does not ablate or damage tissue outside of the targeted area and that the device is as effective at ablating prostate tissue in the targeted area as a similar device with an equivalent safety profile.
Prior to initiating a clinical investigation for prostate tissue ablation devices, the FDA encourages manufacturers to contact the FDA with a Pre-Submission to obtain detailed feedback on the clinical investigation planned.
The scope of this draft guidance is limited to the clinical investigations to support marketing authorization for general indications of prostate tissue ablation systems. This draft guidance does not address the clinical investigations of devices that are intended to treat specific prostatic diseases, such as prostate cancer or benign prostatic hyperplasia. Disease-specific studies use different endpoints and study designs to demonstrate safety and effectiveness compared to a study to demonstrate effective tissue ablation.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.