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


Companies should use existing registry data

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers should tap into data from existing device registries to help fulfill post-approval study requirements in a practical way, FDA says. The agency has been devoting significant resources lately to improving its approach to post-market studies required as a condition of approval for many PMA devices. By using existing registries - such as the American College of Cardiology's National Cardiovascular Data Registry - firms can answer questions about the real-world performance of products without starting a new trial from scratch, Danica Marinac-Dabic, epidemiology director in CDRH's Office of Surveillance and Biometrics, said at a Sept. 9-10 public workshop at FDA's White Oak Campus in Silver Spring, Md. The registries also "play a critical role in device surveillance," added Tom Gross, deputy director of post-market science at OSB. However, FDA points out that registries cannot replace prospectively designed observational studies in all cases. The agency requests varying study designs based on "the value and the quality of the pre-market data," Marinac-Dabic 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