Align Technology Warned for Failure to File MDRs

Align Technology, the maker of Invisalign orthodontic devices and appliances, has received a warning letter for failure to report adverse events within 30 days. Although the company received a complaint indicating that a patient had to be treated with a steroid due to adverse events that occurred after using the Invisalign system, it did not submit a medical device report (MDR), according to the letter posted last month. The company responded to the warning letter and included the documentation the FDA requested. It has asked to meet with the agency to ensure that the issues in the warning letter have been fully addressed, Roger George, Align’s vice president and general counsel, says.
The GMP Letter