The FDA Announced today that it reached a settlement with Globus Medical Inc. for the distribution of unapproved medical devices. The FDA and Globus Medical agreed to a $1 million civil money penalty settlement that requires the company to pay a $550,000 penalty and David C. Paul, the firm’s CEO, to pay a $450,000 penalty.
The settlement concludes a case that began in the Fall of 2010. During an inspection of Globus Medical in September 2010, FDA investigators learned that the company had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, as required by law.
“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 not found to be safe and effective,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We took action against Globus Medical to protect patients and we are pleased with the outcome.”
The decision to distribute the unapproved device was intentional. 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.
The FDA then filed a complaint for civil money penalties against Globus Medical and the company’s CEO for distributing the NuBone product without proper FDA approval or clearance. The agency informed Globus Medical and Paul of this action in November 2011, and later participated in settlement discussions leading to the $1 million penalty agreement.
“This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”
It’s not clear what guided Globus Medical’s decision to sell the device despite the NSE letter. What remains clear after the settlement annouced today – the distribution of unapproved medical devices will not be tolerated, especially where the Agency examined and refused to clear a device during the pre-market approval process.
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