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


CBER (Center for Biologics Evaluation and Research) look at its input for device industry:

This article was originally published in Clinica

Executive Summary

FDA's biologics centre is developing metrics for measuring how well it meets the needs of the device companies it regulates. The Center for Biologics Evaluation and Research (CBER) has been criticised for years for its slow review of the blood product devices and other products classified as devices that fall within its purview. At the AdvaMed annual meeting a year ago, the biologics centre insisted that it was reviewing device products on time, but could offer no statistics to back up that claim. Part of the problem is that CBER does not use the same definitions as industry, CBER deputy director Jesse Goodman admitted at this year's AdvaMed annual meeting held earlier this month in Carlsbad, California. CBER met with officials from the device industry on March 1 to talk about "recalibrating the difference in review metrics," he said.

You may also be interested in...

Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Start-Up Spotlight: Iraq War Veteran Deploys ‘Bone Paint’ To Combat Traumatic Injuries

Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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