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Device Review Improvements Not Expected Until FY 2005 Under MDUFMA

This article was originally published in The Silver Sheet

Executive Summary

MEDICAL DEVICE USER FEES are expected to lead to a 25% reduction in premarket review times at the end of five years. Under the "Medical Device User Fee and Modernization Act," signed by President Bush Oct. 26, manufacturers will pay FDA a range of fees – from $154,000 for PMA reviews to $2,187 for 510(k)s – in return for the agency’s commitment to meet increasingly strict cycle review and decision goals as the program matures. Fees will fund a number of review-related activities, including pre-approval inspections, clinical trial monitoring and standards development. The Center for Devices and Radiological Health has assigned various teams to begin implementing the new program and to assess how user fees will affect operations across the center

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