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US FDA Asks Prostate Ablation Device-Sponsors For More Clinical Safety Data To Support Clearances

Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.

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Makers of devices used to carve out or destroy prostate tissue, such as certain ultrasound technology, could be required to provide additional safety and effectiveness data before regulators in the US clear them for marketing. The US Food and Drug Administration sets out the type of information and clinical trial protocols it’s looking for from sponsors before green-lighting certain ablation products.

On 25 June, the FDA published a proposed guidance titled, “Clinical Investigations for Prostate Tissue Ablation Devices,” that outlines...

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