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

Shuren Defends Tentative User Fee Agreement On The Hill

This article was originally published in The Gray Sheet

Executive Summary

Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.

You may also be interested in...



Industry, FDA Agree On Draft User Fee Commitment Letter

Draft commitment and legislative language come one month after agreement “in principle” on MDUFA III reauthorization.

Draft User Fee Bills Aim To Streamline And Strengthen Device Regs

Details on draft legislation circulating in the House and Senate.

FDA Sets March 28 Date To Discuss Newly Published Draft User Fee Pact

The agency published its draft commitment letter and draft legislative language for user fee reauthorization March 15. A public meeting is set for the end of the month, and public comments will be accepted through April 16.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT030984

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