FDAnews
www.fdanews.com/articles/90072-company-must-stop-selling-products-without-approval

COMPANY MUST STOP SELLING PRODUCTS WITHOUT APPROVAL

January 19, 2007

TMJ Implants must stop promoting devices on its website without premarket approval from the FDA, a recent warning letter said.

Because the company's hemi and full mandibles lack premarket clearance, the products are adulterated and misbranded, the agency said.

According to the FDA, TMJ's website claims the company can design hemi and full mandibles for unusual patient needs. For example, the website says the company has created solutions for "unusual conditions" like Treacher Collins and Goldenhar syndromes. The website also says TMJ has handled cases involving trauma to the mandible and temporomandibular joints, cancer and tumors, the letter said.

But TMJ did not inform the FDA of its intent to sell the hemi and full mandibles, the warning letter said. TMJ must obtain either a new premarket application or a supplement to one of its approved applications to legally market the devices, the FDA said. (http://www.fdanews.com/ddl/34_3/)