Inspections, Compliance, Enforcement, and Criminal Investigations
Thermography and Breast Health Center of Idaho, 10/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring. MD 20993
OCT 26 2009
VIA FEDERAL EXPRESS
Thermography and Breast Health Center of Idaho
Rose Thomas, N.D.
330 North Orchard Street
Boise, ID 83706
964 North Stolle Place
Meridian, ID 83642
Re: CRT 2000® Thermographic System
Refer to GEN0900909 when replying to this letter.
Dear Dr. Thomas:
The Food and Drug Administration (FDA) has learned that your facility is marketing the CRT 2000® Thermographic System in the United States (U.S.) for uses that have not received marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product 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 is intended to affect the structure or function of the body. The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed your website, at http://www.drrosethomas.com. for the CRT 2000® Thermographic System product. Your website promotes the CRT 2000® for uses for which you have not obtained marketing approval or clearance, which is a violation of the law.
The CRT 2000® Thermographic System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the new intended uses. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http/www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Specifically, the CRT 2000® Thermographic System was cleared via premarket notification (510(k)) K971956 for the indications for use for adjunctive diagnosis of abnormalities of the female breast, peripheral vascular disease, muscloskeletal disorders, extracranial cerebral and facial vascular disease. abnormalities of the thyroid gland, and various neoplastic and inflammatory conditions. The CRT 2000® is not intended to serve as sole diagnostic screening procedure. Your website contains the following statements which represent or suggest that the CRT 2000® Thermographic System, also described as Computerized Regulation Thermography, is intended for use as a sole diagnostic procedure:
• On the homepage of your website, it states "[f]or those of you who avoid having a mammogram for whatever reason ... There IS a non invasive option! NO X-ray radiation. NO infrared radiation. Most comforting of all: NO squish, NO compression!" Further, Your website also contains an advertisement that states "Computerized Regulation Thermography finds dysfunction early so it can be addressed to possibly avoid a devastating disease or terminal illness (emphasis added)." In addition, the Frequently Asked Questions section contains a question "Why Should I choose Thermography over Mammography?" These statements indicate that the sensitivity of the CRT 2000® is greater than mammography, which is a primary breast cancer diagnostic procedure, and that the CRT 2000® can be used alone as a primary diagnostic screening procedure, for which it has not been approved.
• Your website states that "Computerized Regulation Thermography can discover possible sources of chronic disease and infections. Breast, ovarian, and prostate health can also be assessed. Possible cardiovascular, stomach, liver, pancreas, and gallbladder problems. Unknown causes of infection, inflammation, allergic or toxic reactions to food and/or environmental toxins, intestinal mycosis or dysbiosis, correlations between dental health and much more." These claims once again indicate that the CRT 2000® can be used for sole diagnosis of chronic diseases and conditions, for which it has not been cleared or approved. Additionally, the above statements represent organ systems and specific diseases and conditions that are not covered in the CRT 2000® Thermographic System's cleared indications for use.
The FDA requests that you immediately cease making claims, identical or similar to those described above, for this product. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials that are the same as or similar to those described above, for this product, and explaining your plan for discontinuing use of such materials. Please direct your response to Jennifer R. Medicus, Acting Branch Chief, Radiology, Anesthesiology, and Neurology Devices Branch, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993-0002, facsimile at (301) 847-8138. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for this product comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health
cc: Christopher Ball, Ph.D.
Acting Laboratory Bureau Chief
Idaho Department of Health and Welfare
Division of Health
Bureau of Laboratory
2220 Old Penitentiary Road
Boise, ID 83712