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

Report: FDA Greenlit Record Diagnostics, Improved PMA Decision Times Despite COVID-19

Executive Summary

Despite industry concerns the US FDA may be significantly falling behind on non-COVID-19 product reviews, analysts at Wells Fargo find that the agency has actually improved in areas such as PMA decision times.

You may also be interested in...



A Chat With Jeff Shuren: FDA Device Center Chief Worries About Agency Staffing; Talks MDUFA V, Pandemic, More

The head of the US agency’s device center spoke with Medtech Insight in an exclusive wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.­

Q1 Recalls Snapshot: It’s A Mixed Bag As Device Recalls Fall 10% But Recalled Units Rise 3%

Recalls initiated by the medical device industry were relatively stable in the first quarter of 2021 as companies recalled 212 products, a 10% decrease from the previous quarter. Check out our Q1 recalls infographic for more.

MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments

The most recent Medical Device User Fee Amendments meeting minutes expose how the US agency and the medtech industry continue to disagree over the agency’s previous user-fee commitments and desire to get more funding.

Topics

UsernamePublicRestriction

Register

MT144147

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