Align Technology Inc – FDA Warning Letter, Aug 9, 2010

On November 17, 2010, the FDA issued a Warning Letter to Align Technology, Inc., following an inspection from June 29, 2010, to August 9, 2010, at their San Jose, California facility. The inspection determined that the firm manufactures the Invisalign System, including orthodontic devices and appliances, which are classified as medical devices.

The inspection revealed that the Invisalign System devices are misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, due to the firm's failure to furnish material or information required by section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation.

Specific violations included: 1. Failure to submit reports of individual adverse events within 30 calendar days of becoming aware of information suggesting a device caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). An example cited was Complaint ID (b)(4), where a patient received steroids for adverse events (swelling) subsequent to Invisalign use, with the firm becoming aware on March 17, 2008. 2. Failure to submit reports of individual adverse events within 30 calendar days when a device malfunctioned and a recurrence would likely cause or contribute to a death or serious injury