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 San Jose, Calif., 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 warning letter.

The company has responded to the warning letter and included the documentation the FDA requested, according to Roger George, Align’s vice president and general counsel. It has asked to meet with the agency to ensure that the issues in the warning letter have been fully addressed, George says.
The GMP Letter