FDA aims to accelerate medical device reviews

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

The so-called Innovation Pathway from the would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new devices. The initiative comes amid complaints from medical device manufacturers that FDA review times lag behind other regulators abroad.

Medical device executives say it takes the FDA about twice as long to review new devices as their counterparts in the European Union, according to an industry survey released last month by PriceWaterhouseCoopers.

The said an innovative prosthetic arm developed by the Department of Defense would be the first device to use the new system.

©2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Citation: FDA aims to accelerate medical device reviews (2011, February 8) retrieved 10 May 2024 from https://medicalxpress.com/news/2011-02-fda-aims-medical-device.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Explore further

FDA medical device approvals get external review

 shares

Feedback to editors