Warning Letter: Clearance of a component does not permit marketing with a major change or modification in intended use (ucm540528)

The United States Food and Drug Administration (FDA) has learned that your firm, Thermogram Assessment Services (TAS), is marketing the TAS Image Analysis Software, including the Spatial Thermographic Imaging (STI),^[1] the Integrated Thermography Systems, and Infrared (IR) Cameras (FLIR Systems, Inc. Model 325 and Model 655) (hereinafter referred to collectively as the “TAS Thermal Imaging System”), in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act)…

In communications with FDA you seem to argue that your marketing of the TAS Thermal Imaging System is permissible because the device has been cleared by FDA.  For example, you stated in your September 1, 2015 letter to FDA that the “equipment, systems, and software offered on [your] web site are brokered products available from FLIR Commercial Systems Inc., and which have been cleared for marketing by the FDA for sale.”

This software is also referred to by other names, including the “Breast Thermography Evaluation Program,” “Computerized Breast Thermography (CBT) software program,” “proprietary interpretation software”, “Spatial Thermographic Imaging”, and “artificial intelligence computer program”, on the TAS’s websites identified in this letter.

View original warning letter.