New England Journal Agrees FDA Device Process Must be Overhauled

The New England Journal of Medicine agrees with the Institute of Medicine that the FDA's 510(k) medical device approval program must be overhauled, according to a report by Mass Device.

 

An editorial in the journal said the FDA's process of using existing devices as the basis for evaluating safety and effectiveness of a new device is "untenable" and should be stopped immediately for Class III devices.

 

Answering device industry concerns that a more extensive review would be a burden, the journal noted ongoing lawsuits on metal-on-metal hip implants that could cost Depuy Orthopaedics up to $1 billion.

 

Read the Mass Device report on overhauling the FDA's medical device approval process.

 

Related Articles on the FDA Medical Device Approval Process:

FDA Clarifies Device Approval Process

FDA Seeking Comment on IOM Device Recommendations

FDA Proposes Updating Device Reviews, Including for Joints, IOLs


 

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers