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

‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic

Device center chief reiterates during AdvaMed podcast that pre-sub meetings for many products won’t happen until 2022

Executive Summary

US FDA device center director Jeff Shuren is asking whether the agency’s engagement with industry has been changed forever because of COVID-19.

You may also be interested in...



IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows

Jeff Shuren, director of the US FDA’s device center, promised in a podcast interview with AdvaMed that the agency’s backlog of in vitro diagnostic submissions not related to COVID-19 will begin abating “in the next few weeks.”

Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile

Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.

Top CDRH Officials Tell EUA Holders: Don’t Procrastinate In Getting Products FDA-Approved

Makers of devices and tests granted emergency use authorization by the US FDA are being urged by the agency to not wait until the COVID-19 public health emergency is over to get their products approved – assuming they want to keep them on the market post-pandemic.

Topics

UsernamePublicRestriction

Register

MT144085

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