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-Senate Versions Married In Latest User-Fee Bill, Up For July 12 House Debate

Executive Summary

Differences between Senate and House Committee versions of the FDA Reauthorization Act passed in May and June to approve five-year device user-fee agreements have been smoothed over by committee staff and joined together in the latest version of the act. The bill has been placed on the House's calendar in anticipation of July 12 action to debate and approve the bill. Next steps in the Senate, meanwhile, remain to be seen.

You may also be interested in...

US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate

The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.

Timing On User Fee Votes Up In Air, As GOP Delays Senate Health Care Bill Battle

Senate leaders had shoved a floor vote on the five-year device and drug user fee reauthorization bill to the back burner to make room for a pre-July 4 vote on the Senate's Obamacare repeal bill, the Better Care Reconciliation Act. But Senate Majority Leader Mitch McConnell is now delaying a vote to get more votes, a step that could further throw off the timing of FDARA passage.

House Committee Advances User Fees With Full Slate Of Device Amendments

House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.

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