FDA Issues Warning to Invisalign Maker.
Posted By Power & Brown, LLC
The AP(12/3) reports, "The Food and Drug Administration has issued a warning to" Align Technology, Inc., "a company that makes a popular teeth straightener" -- the Invisalign system -- "about its failure to report information about patient side effects." The company "disclosed this week that it received a Nov. 18 warning letter from the FDA following an inspection this summer" in which the agency accused it "of failing to comply with federal requirements to report serious side effects associated with medical devices," such as patients' allergic reactions. According to the manufacturer's general counsel, the company is working with the agency to resolve the situation.