FDA’s Globus Oops (Walter Eisner @ OTW)
Oops.
The FDA has changed a statement made in a February 28 press release announcing a $1 million dollar penalty settlement with Globus Medical, Inc. and its CEO for marketing an unapproved medical device.
The agency originally wrote: “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.”
In fact, the agency made no such finding. The FDA did not determine that the product was not safe and effective and Globus asked the ...
The Orthopedics Industry 
