Regulatory Focus™ > News Articles > Medical Device Firm Accused of Selling Unapproved Medical Devices Fined $1 Million

Medical Device Firm Accused of Selling Unapproved Medical Devices Fined $1 Million

Posted 29 February 2012 | By Alexander Gaffney, RAC 

Globus Medical Inc., a Pennsylvania-based medical device manufacturer, has reached an agreement with the US Food and Drug Administration (FDA) to pay a $550,000 fine for reportedly violating the federal law by distributing unapproved medical devices.

The firm's Chief Executive Officer, David C. Paul, will reportedly pay FDA an additional $450,000, bringing the total fines collected by FDA for the infraction up to an even $1 million.

"The device-clearance process assures the quality and safety of devices before they reach the market. Firms can't simply choose to sell devices that FDA has found are not safe and effective," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health (CDRH).

According to FDA, "Globus Medical had sought clearance of its NuBone product in January 2009, but the FDA declined to clear the product after determining that it was not substantially equivalent (NSE) to legally-marketed products. The FDA advised Globus Medical that it could not distribute the product, but the firm continued to do so, even after receiving the NSE letter in December 2009."


Read more:

FDA reaches $1 million settlement with Pennsylvania medical device firm

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe