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


House Passes Compromise User Fee Bill; Senate To Vote This Week

This article was originally published in The Gray Sheet

Executive Summary

The final bill includes device user fee reauthorization and additional FDA reforms, including a streamlined device reclassification process that has some in the device industry nervous.

You may also be interested in...

Regulatory News In Brief

FDA proposes reclassification of three devices. Group calls for release of all clinical trial data. More regulatory news.

FDA Subject To More Oversight Following User Fee Bill Passage

The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.

On Eve Of User Fee Reform, Some Minnesota Firms Signal Skepticism

A survey of Minnesota device executives released last week closely aligns with previous industry polls, but the timing is notable: it comes just as Congress is completing passage of a user fee reauthorization bill championed by national device groups.

Related Content


Latest News
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