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

COVID-19-Related EUAs Bolster Record Number Of Novel Devices Greenlit By FDA

Executive Summary

According to top FDA officials Jeff Shuren and William Maisel, regulators approved, cleared and authorized 132 novel devices up from its previous record of 106. It’s in large part due to EUAs for novel COVID-19 products issued last year.

You may also be interested in...



FDA’s Shuren: Staff Overburdened, Review Times Seeing Negative Effects

The head of the US agency’s device center tells Medtech Insight that while he’s proud of his staff for taking on the extra workload due to the pandemic, product review times are slowing because resources are stretched thin.

Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic

On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.

New AdvaMed Board Chair To Make Military Veteran Recruitment A Priority

A former Army ranger, Michael Minogue wants to help military veterans transition into and gain employment opportunities in the medtech industry.

Topics

UsernamePublicRestriction

Register

OM017181

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