DEVICEMAKER CHALLENGES FDA OVER PROPOSED INJUNCTION
Orthopedic devicemaker Endotec said it will challenge an FDA complaint in court and argue that the agency lacked adequate information when it sought a permanent injunction against the company.
The company's Oct. 17 announcement said the FDA did not have evidence of violations and made its complaint so vague that Endotec could not respond.
The FDA filed a complaint in August seeking a permanent injunction against Endotec, alleging illegal distribution of joint replacement devices. According to the FDA, Endotec sent, received and implanted devices without premarket approval. The agency first sent a letter warning Endotec of the possibility of an injunction in 2002.
Endotec said the FDA's complaint resulted from different interpretations of a law that exempts custom devices from FDA regulation. The FDA has not yet published guidelines clarifying the law's meaning, Endotec said. The company added it hopes the court decision will call for the FDA to create such guidelines.