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GAO user fee report

This article was originally published in The Gray Sheet

Executive Summary

The vast majority of device manufacturers qualifying as small businesses in fiscal year 2006 under the Medical Device User Fee and Modernization Act of 2002 had revenues under $10 million, while most publicly traded companies that did not qualify had revenues of more than $500 million, according to a Government Accountability Office 1report sent March 30 to Rep. Joe Barton, R-Texas, ranking minority member of the House Committee on Energy and Commerce. The original MDUFMA-mandated threshold for small businesses to qualify for fee reductions for submissions including PMAs and 510(k)s was $30 million, but that amount was increased to $100 million by the Medical Device User Fee Stabilization Act of 2005. Of the 697 companies that qualified as small businesses in 2006, 656 or about 95%, had revenues at or below $30 million, and 35 had revenues between $30 million and $70 million, according to GAO. Small business submissions accounted for roughly 20% of all device applications subject to user fees submitted in 2006. The House Committee on Energy and Commerce requested the report to determine if changes to the current small business threshold are needed under a reauthorized version of MDUFMA that would take effect Oct. 1...

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