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

$30m In Device User Fees Will Go To Real-World Evidence Evaluation System

Executive Summary

US FDA will be able to tap $30m in user fees over a five-year span to support an independent coordinating center for collection of real-world evidence under its nascent NEST program, according to device center Director Jeff Shuren.

You may also be interested in...



Pilot Of New US Evaluation System Will Include At Least Two Devices

New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.

MDIC Snags $3m For FDA Real-World Evidence Coordinating Center

FDA has awarded the Medical Device Innovation Consortium $3 million to create a "coordinating center" to develop an envisioned National Evaluation System for health Technology, which will leverage real-world evidence to support device approvals and safety and performance tracking.

Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations

FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103807

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