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

FDA Asks For Input On Best Ways To Support Premarket Use Of Real-World Evidence

Executive Summary

The US Food and Drug Administration is seeking public comment on how best to allocate funds authorized under the latest installment of the Medical Device User Fees Amendments to support premarket real-world evidence.

You may also be interested in...



Additional User Fee Funding Will Boost Global Harmonization, Says FDA’s Torres

Recently passed legislation that includes higher medical device user fees will allow the US FDA to put more resources into establishing global harmonization standards with international partners.

Lifting The Hood On MDUFA V

The document includes promises from the US FDA related to review timelines, consensus standards, the Total Product Life Cycle pilot, and more.

News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants

Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT147553

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