iThe Office of Compliance (OC) in the FDA’s Center for Devices and Radiological Health issued a warning letter to NeoMedix Corporation regarding the Trabectome High Frequency Generator /LP (Trabectome) on February 26, 2014.
The warning letter included allegations that Neomedix’s website made claims about Trabectome that represented a “major change or modification” of the device’s intended use, including claims for minimally invasive surgical treatment and management of glaucoma. Because of the website’s claims, OC alleged that the device was adulterated and misbranded.
Additional information on this warning letter, and other enforcement letters related to the advertising and promotion of drugs and biologics, can be found in Covington & Burling LLP’s e-alert for the month of March (available here).
