Medtech Insight is part of the Business Intelligence Division 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

MDUFA IV Fees Unveiled: Changes For 510(k)s, Small Business, De Novos

Executive Summary

Prior to a Nov. 2 public meeting on the tentative MDUFA IV deal between FDA and industry, the agency released its proposed commitment letter and new details on the structure of user fees in the deal, including an increased 510(k) rate, more protection for small businesses and a new fee for de novo submissions.

Advertisement

Related Content

Senate, House Panels Release Clean Device User-Fee Discussion Draft
US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals
Public Invited To Vet Draft User-Fee Agreement At Nov. 2 Meeting
MDUFA IV Takes Shape: A Catalogue Of Draft Commitments
Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations

Topics

Advertisement
UsernamePublicRestriction

Register

MT104013

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