GAO user fee report
This article was originally published in The Gray Sheet
Executive SummaryThe 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...
You may also be interested in...
Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.
We clean out your Martin Luther King Day inbox so you don't have to.
Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.