CDRH Issues Warning Letter for Device Cancer Diagnosis Claims in Brochures, on Website

Feb. 28, 2019 – In a rare promotion-related enforcement action, the FDA’s Center for Devices and Radiological Health (CDRH) issued a Warning Letter to Total Thermal Imaging Inc. (TTI) for claims made about its Thermography Business Package product in the firm’s brochures and on its website.

Following an inspection of the firm in summer 2018, CDRH issued a Warning Letter Feb. 22 citing that the company’s website and brochures “revealed TTI is marketing the Thermography Business Package as a sole screening device for breast cancer and other diseases.” For example, the letter states, TTI’s website and brochures contain the following claims and indications, among others:

  • “Thermal Imaging is intended for early detection of the diagnosis of many disorders including breast cancer, inflammatory breast cancer, pre-stroke, heart disease, deep vein thrombosis, reflex sympathetic dystrophy/complex regional pain syndrome, back, leg or headache, and even unexplained pain, TMJ, and other disease.”
  • “You can’t prevent or cure breast cancer until it is detected. DON’T WAIT! Schedule an appointment with a certified clinical thermographer today. Start by and find a thermal imaging center near you.”
  • “Share with your friends & family that there is an alternative to mammography that doesn’t involve any patient contact (no pain), will not cause cancer (no radiation), and is far more efficient at detecting cancer.”
  • “Breast Screening … This scan looks for inflammation, lymphatic congestion, hormonal imbalances. Early detection saves lives and breasts!”

On Feb. 25, the FDA issued a consumer safety advisory about thermography devices, which stated that such devices, “have been cleared for marketing by the FDA only for use with another screening or diagnostic test like mammography, not for use as a standalone diagnostic tool.”

According to the consumer warning, the FDA is alerting women, healthcare providers, and people getting breast cancer screening, that thermography “is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis,” because “there is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.”

CDRH also cites TTI for marketing a medical device that is adulterated because it requires an approved premarket approval application and misbranded because it does not have a 510(k) premarket notification clearance. Although part of the Thermography Business Package (the FLIR infrared camera) does have a cleared 510(k) for a certain intended use, “such clearance of a component … does not permit the marketing of the Thermography Business Package.” TTI also was cited for good manufacturing practice violations and a failure to fulfill annual registration and listing requirements for fiscal year 2018 or 2019.