FDA Settles For $1M With Pennsylvania Medical Device Firm Over Unapproved Devices

The FDA has reached a $1 million civil money penalty settlement with Globus Medical Inc. for the distribution of unapproved medical devices, according to an FDA news release.

A 2010 inspection revealed that the company had marketed its NuBone Osteoinductive Bone Graft product without prior approval or clearance. The settlement requires the Pennsylvania-based medical device firm to pay a $550,000 penalty and the firm's CEO, David Paul, to pay a $450,000 penalty, for a total of $1 million.

Related Articles on Supply Chain:

FDA Seeks Stricter Regulations on Hip Implants, Vaginal Mesh
Medical Device Industry Reps to Discuss Medical Device Tax With Lawmakers
New Michigan Podiatric Group Looks to Contract Directly With Insurers, Vendors

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

 

Featured Webinars

Featured Whitepapers