Originally Published MX November/December 2002

BUSINESS NEWS

Medical device companies that filed premarket submissions with FDA after October 1, 2002, will be required to pay user fees under the terms of the Medical Device User Fee and Modernization Act of 2002, which was enacted by Congress on October 17 and signed into law by President Bush on October 26.

Passage of the new legislation brings to a close a decade of resistance to user fees among many medical device companies.

Under the terms of the device user fee legislation, FDA is empowered to assess fees totaling $25.1 million in FY03 and increasing to $35 million in FY07. During FY03, the full price for a premarket approval (PMA) application is $154,000; all sponsors of premarket notification (510(k)) submissions will pay $2187 for each such submission.