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


User-Fee Facts: 10 Key Medtech Details From US FDA Agreements

Executive Summary

While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.


Related Content

FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More
Bill Bonanza: US Congress Sprouts Medtech Legislation This Spring
Single Marketing Application Review For Multiple Jurisdictions On Horizon
MDR Reporting: FDA Embraces Adverse Event Summaries Under MDUFA IV, But Flouts Similar FDAAA Mandate
Must-Do Guidance Development: What's On Tap From Cures, MDUFA IV
Device Standards Provision In Cures Bill Could Speed Up 510(k) Clearances
'Cures' Bill Circumvents FDA On Medical Software Regs
Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations
US Device User-Fee Rates Will Drop About 10.3% In Fiscal 2017
FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews





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