United States of America proposed classification of the high intensity ultrasound system for prostate tissue ablation

The Food and Drug Administration (FDA) 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.

Product covered: Gastroenterology-Urology devices

HS code: 9018

Proposed date of adoption: 02-10-2017

Proposed date of entry into force: 02-10-2017

Final date for comments: NA

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