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WARNING LETTER
CMS # 567742

 

HAND DELIVERED

Dear Ms. Hayes:

During an inspection of your firm, Total Thermal Imaging, Inc. (TTI), located in La Mesa, CA on July 3, 2018 through August 2, 2018, investigators from the United States Food and Drug Administration (FDA) determined that TTI manufactures and markets the Thermography Business Package, which includes the (b)(4) software and FLIR Systems, Inc. (FLIR) Infrared Cameras. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the Thermography Business Package is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Our inspection and review of your firm’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, 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 visiting www.totalthermalimaging.com 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!”

Telethermographic systems that are intended for use alone in diagnostic screening for detection of breast cancer or other uses1 have been classified as class III devices under 21 CFR 884.2980(b) and require approval of a premarket approval application (PMA) prior to marketing.2 Because your firm does not have an approved PMA in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the Thermography Business Package, that device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B). The Thermography Business Package is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).3

Although the FLIR infrared (IR) camera included in the Thermography Business Package, has been cleared (for a certain intended use) by FDA, such clearance of a component of the Thermography Business Package does not permit the marketing of the Thermography Business Package. Moreover, marketing the FLIR IR camera with a major change or modification in intended use would not fall under its current clearance. The FLIR IR camera is a class I device regulated under 21 CFR 884.2980(a) (“Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses”), and was cleared by FDA (under K033967) for the following intended use: “The Flir device is intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes.” Marketing the FLIR camera for sole diagnostic screening, for example, by stating that it 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 (see 21 CFR 807.81(a)(3)(ii)), and would require premarket approval (see 21 CFR 884.2980(b)).

Our inspection also revealed that the Thermography Business Package device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm has not established design control procedures. Additionally, TTI has not maintained documentation of the design changes related to the Thermography Business Package.

2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm has no established procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. For example, TTI contracted development of the (b)(4) software, a component of the Thermography Business Package, without established procedures to ensure that the received product and services conform to specified requirements. Additionally, no purchasing control procedures were established to evaluate, select, and monitor suppliers.

3. Failure to establish and maintain procedures for acceptance activities, such as inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). Specifically, there are no acceptance activities performed for receipt or release of the Thermography Business Package.

4. Failure to establish and maintain procedures for corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, there are no defined, documented, or implemented procedures for corrective and preventive actions for the Thermography Business Package, to correct and prevent recurrence of non-conforming product and other quality problems.

5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Specifically, your firm has not established any procedures for complaint handling related to the Thermography Business Package, including the investigation of complaints and the evaluation of whether complaints require reporting to FDA under 21 CFR Part 803.

6. Failure to establish procedures for quality audits and to conduct such audits as required by 21 CFR 820.22. Specifically, your firm has not established any procedures for quality audits of the Thermography Business Package.

7. Failure to establish procedures for training and identifying training needs, as required by 21 CFR 820.25(b). Specifically, your firm has not established any procedures for related to training for the remanufacturing activities associated with the Thermography Business Package.

8. Failure to establish and maintain procedures for management review, as required by 21 CFR 820.20(c). Specifically, your firm has not established any procedures for management review of the Thermography Business Package.

9. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). Specifically, your firm has not defined, documented, or implemented any quality system procedures related to remanufacturing activities associated with the Thermography Business Package.

Finally, our inspection revealed that your firm’s Thermography Business Package device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), because your firm has failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR). Violations observed include, but are not limited to, your firm’s failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

Furthermore, under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Our records indicate that your firm has not fulfilled the annual registration and listing requirements for fiscal year 2018 or 2019. Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

During our inspection of your firm, you indicated that the observations noted by our investigators at the close of the inspection were under consideration by TTI’s management and stated that TTI would respond in writing within fifteen days after the completion of the inspection. As of the date of this letter, FDA has not received such a response.

Your firm should immediately cease distribution of the Thermography Business Package and take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. If relevant, please provide a translation of any documentation not in English to facilitate our review.

Your firm’s response to this letter should be sent to: [email protected]. Refer to Case No. 567742 when replying.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.

Should you have any questions or comments pertaining to this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918 or via e-mail [email protected]. In any follow-up correspondence, please clearly reference CMS Case No. 567742 and include a contact email address.

 

Sincerely,
/S/

Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Operations Division 3/West

 

1 For your reference we note that telethermographic systems that are intended for adjunctive diagnostic screening for the detection of breast cancer or other uses have been classified as class I devices under 21 CFR 884.2980(a) and require premarket clearance (510(k)) prior to marketing. However, even if the Thermography Business Package is intended for adjunctive screening for detection of breast cancer or other uses, it may not be found substantially equivalent to a legally marketed device (predicate) currently classified under 21 CFR 884.2980(a) if your firm’s device has different technological characteristics from the predicate device that raise different questions of safety and effectiveness from the predicate device. See section 513(f) of the Act, 21 U.S.C. § 360c(f), and the implementing regulations found at 21 CFR 807.100.
2 The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
3 For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency as defined by 21 CFR 807.81(b).