FDA WARNING_LETTER - Total Thermal Imaging, Inc. - August 02, 2018

The FDA issued a Warning Letter to Total Thermal Imaging, Inc. (TTI) following a July-August 2018 inspection, identifying significant violations related to their Thermography Business Package. TTI marketed this device, intended for sole diagnostic screening of breast cancer and other diseases, as a Class III device without an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE, rendering it adulterated (21 U.S.C. § 351(f)(1)(B)). It was also misbranded (21 U.S.C. § 352(o)) due to the absence of a 510(k) premarket notification. Marketing the FLIR IR camera component for sole diagnostic screening constituted an unapproved change in intended use. Furthermore, the device was adulterated (21 U.S.C. § 351(h)) due to widespread non-compliance with Quality System (QS) regulation (21 CFR Part 820). Deficiencies included failures to establish procedures for design controls, purchasing controls, acceptance activities, CAPA, complaint handling, quality audits, training, management review, and general QS procedures. The device was also misbranded (21 U.S.C. § 352(t)(2)) for failing to furnish required Medical Device Reporting (MDR) information and implement MDR procedures (21 CFR 803.17). Finally, TTI failed to complete annual establishment registration and device listing for FY 2018 and 2019, misbranding all devices (21 U.S.C. § 352(o)). TTI must immediately cease distribution and submit a comprehensive response within fifteen business days detailing corrective actions and prevention plans to avoid further regulatory enforcement.