Today, the FDA issued a draft guidance to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high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 This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or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 ...
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