FDA tells Invisalign Maker to Report Side Effects
Abstract:The FDA has issued a warning letter to Align Technology Inc., a company that makes a popular teeth straightener, the Invisalign system, on its failure to report information about patient side effects. The warning letter accused the company of failing to comply with FDA requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.
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