In November, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) posted on its website four warning letters relating to the advertising and promotion of medical devices:
- Warning letter to Quanta Systems, S.p.A. re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18, 2012)
- Warning letter to NeuroMed Devices, Inc. re: ViraCalm and OraCalm products (October 22, 2012)
- Warning letter to oBand Centers re: the LapBand gastric banding system (November 2, 2012)
- Warning letter to Tonica Elektronik, A/S re: Magnetic Stimulators (November 6, 2012)
On December 28, Covington published a client alert summarizing the CDRH OC’s allegations in these letters. The Warning Letters alleged that these devices were promoted with claims that were outside the cleared or approved uses of the devices or claims that omitted or minimized risk information.
See our full client alert for more details about these allegations and for a summary of recent untitled letters relating to drug promotion and advertising.