Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Post-MDUFMA Technical Corrections Would Include Small Business User Fees

This article was originally published in The Gray Sheet

Executive Summary

FDA will seek help from MDUFMA legislators in passing several technical amendments to the device user fee law, including a provision clarifying that small companies are required to submit the full 510(k) amount for FY 2003

You may also be interested in...



McClellan’s “Strong FDA” Is Unfazed By Device Appropriations Shortfall

FDA is assuring medical device execs that the Bush Administration is united in seeking the additional appropriations required by MDUFMA, but cannot guarantee that funding benchmarks will be met by 2004

McClellan’s “Strong FDA” Is Unfazed By Device Appropriations Shortfall

FDA is assuring medical device execs that the Bush Administration is united in seeking the additional appropriations required by MDUFMA, but cannot guarantee that funding benchmarks will be met by 2004

Enzi Urges 510(k) Fee Clarification: Small Businesses Should Pay Only 80%

Device manufacturers qualifying as small businesses should not be required to pay the full user fee amount for premarket notification submissions in fiscal 2003, according to Sen. Michael Enzi (R-Wyo.)

Latest Headlines
See All
UsernamePublicRestriction

Register

MT018056

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