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

Most FDA User Fees Will Increase By Almost 4% Next Fiscal Year

Executive Summary

US FDA has released its 2019 device user-fee schedule, setting inflation-adjusted rates based on the MDUFA IV framework. Most applications regardless of company size will see a 3.9% increase. That's a far cry from the 32% user-fee increase for most application types in fiscal year 2018.

You may also be interested in...



Medtech Firms To See Significant User Fee Increases In FY 2020

Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.

Fixing Reimbursement ‘Valley Of Death’ And Repealing The Device Tax Are Top MDMA Priorities, CEO Leahey Says

In an interview about medical device lobbying priorities, the Medical Device Manufacturers Association CEO Mark Leahey talked about efforts to figure out administrative and potentially legislative solutions to gain reimbursement for products sooner after FDA approval. Leahey also argues industry groups are in a better position to permanently repeal the 2.3% medical device excise tax despite previous failures to do so.

US FDA Fees To Spike In FY 2018, But Small Firms Get Breaks

The standard US FDA fee for a 510(k) submission will increase 124% in FY 2018, but small companies will see a much more moderate 12% jump. Other fees will increase by between 30%-40% in the coming fiscal year. And, perhaps, the biggest change will be for de novo submissions, which will have a user fee for the first time. FDA issued its inflation-adjusted user-fee schedule following the recent enactment of MDUFA IV.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT123047

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