The FDA this week released a warning letter it sent to Thermogram Assessment Services over a lack of federal clearance or approval for devices it markets.
The agency identified the Palos Verdes, Calif.-based company’s Spatial Thermographic Imaging and Integrated Thermography Systems, as well as its infrared cameras as devices intended for use in diagnosing diseases or other conditions or for use in curing, mitigation, treatment or prevention of disease without the appropriate clearance.
The Federal watchdog said it has communicated with the company previously, in letters in July and November 2015, over clearance issues related to the TAS Thermal Imaging System.
While the FDA said that the infrared cameras offered as part of the system have been cleared for certain intended uses by the agency, the clearance of the components “does not permit the marketing of the TAS Thermal Imaging System,” according to the warning letter.
The Agency said the cameras were cleared “as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying and screening of differences in skin surface temperature changes.”
“Marketing these devices for sole diagnostic screening, for example, by stating that they can be used without any other test in the case of negative findings, would constitute a major change or modification in the intended use of the device […] and would require premarket approval,” the FDA wrote in its warning letter.
The FDA requested that the company “immediately cease activities that result in the misbranding or adulteration of the TAS Thermal Imaging System,” and offered 15 business days to respond to the warning letter.