Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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...

You may also be interested in...



Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

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.

In Case You Missed It … News On China Patents, EMA Chief, And More

We clean out your Martin Luther King Day inbox so you don't have to.

At Muted J.P. Morgan, Focus Is Execution, But US Pricing Is Persistent Overhang

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.

UsernamePublicRestriction

Register

MT024643

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel