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FDA Begins Device User Fee Collection; Appropriations Still In Doubt

This article was originally published in The Silver Sheet

Executive Summary

MEDICAL DEVICE USER FEE PERFORMANCE GOALS may not be met if promised increases in appropriations for premarket activities are not provided, FDA officials warn. Nevertheless, the Center for Devices and Radiological Health is committed to making progress on its performance goals with available funds and plans to hire about 40 device review staffers over the next two years. CDRH is focusing on educating manufacturers on how to follow new user fee payment procedures to avoid review delays. New guidance for firms eligible for small business discounts is due out this summer

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