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...



QUOTED. 4 December. Eric Borin.

Becton Dickinson will spend $1.2bn over the next four years to improve its drug-delivery device manufacturing capabilities. See what Eric Borin, president of BD, said about it here.

Pfizer’s Expected 2020 COVID-19 Vaccine Production Fell By 50% After Scaleup Delays

Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.

Azurity’s Xatmep Promotional Email To Healthcare Professionals Gets Dinged By US FDA

In second letter this year targeting email communications, OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’ comparable to the information on the drug’s effectiveness for the treatment of acute lymphoblastic leukemia that was in the body of the email.

UsernamePublicRestriction

Register

OM002409

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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