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510(k) user fees

This article was originally published in The Gray Sheet

Executive Summary

Clarification of FDA's FY 2003 device user fee policy will be issued in an upcoming Federal Register notice. Language in an earlier Nov. 21 notice "may confuse readers concerning the fee that must be paid by a small business that submits a 510(k)" application, according to the agency's MDUFMA web site. "With limited exceptions," all firms must pay $2,187 for FY 2003 applications. Reduced 510(k) fees for small companies will be effective in FY 2004...
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