CDRH Cites Off-Label Claims in Online Marketing Efforts

Online marketing claims for unapproved uses of devices resulted in warning letters to King Systems and the Thermography and Breast Health Center of Idaho. The letters, both dated Oct. 26, were the result of CDRH reviews of the companies’ websites. The King letter cites indications for the LTS-D Airway that have not been cleared. The health center letter cites promotion of the CRT 2000 thermographic system as a sole diagnostic system when it has been cleared only for adjunctive use.
Devices & Diagnostics Letter