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


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

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...

CDRH Extends Device Establishment Registration Deadline

The device center has extended the annual medical device registration period by one month to Jan. 31, as companies and FDA adopt new registration and registration fee requirements established in the FDA Safety and Innovation Act and recent regulatory revisions.

Patient, Consumer Groups Decry Lack Of User Fee Funding For Post-Market Surveillance

Non-industry stakeholders criticized the medical device user fee agreement for not giving FDA enough funding, particularly to enhance post-market surveillance programs, during an FDA public meeting on user fee reauthorization.

HELP Committee Leaders Aim To Prevent Controversial Add-Ons To User Fee Bill

Members of the Senate HELP Committee expressed concerns that potential riders added to the FDA user fee bill could slow down passage and add more work for FDA staff.

Related Content


Latest Headlines
See All



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