|The FDA says NuVasive has been improperly marketing its Affix device.--Courtesy of NuVasive|
The FDA slapped NuVasive ($NUVA) with a warning letter over its line of spinal fixation devices, saying the company has been selling the product for uses not approved by the agency.
NuVasive's Affix Spinous Process Plate System is used to clamp spinal grafts in place during surgery, but the FDA says the tech is misbranded, as the company bills it as useful in interbody fusion procedures without getting an agency sign-off. Affix has a slew of 510(k)-cleared indications on the books, the FDA says, but that's not one of them.
Now, NuVasive has 15 business days to get back to the agency with a plan on how it will rectify the issue and keep it from popping up again. That likely means suspending the marketing of Affix for unapproved indications and going through the FDA clearance process in the meantime.
Just how long NuVasive expects the effort to take remains unknown; the company didn't respond to a request for comment Tuesday.
If NuVasive fails to change its ways to the FDA's liking, it risks seizure, injunction and fines, the agency notes, and, as Hospira ($HSP) can attest, the FDA isn't shy about banning devices from sale when it believes companies have run afoul of its regulations.
- read the FDA's warning letter