Medtech Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview

Executive Summary

In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.

You may also be interested in...



FDA Meeting Will Focus On Aggregating Patient-Generated Health Data

The topic is central to the Patient Engagement Advisory Committee, which recently got its tenure extended. It also fits into the FDA’s thinking on real-world evidence and total product lifecycle approach.

Top FDA Officials Tout Use Of Real-World Evidence Based On New Report

The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.

US FDA Recognizes Case For Quality Collaborative Community

The Case for Quality Collaborative Community – or CfQcc – affords stakeholders across industry a safe space where they can rally around an array of topics to advance medical device quality and safety.

Related Content

Topics

UsernamePublicRestriction

Register

MT126345

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