Department of Health and Human Services
Public Health Service
|200 Corporate Boulevard
Rockville MD 20850
July 26 , 2007
VIA FEDERAL EXPRESS
Mr. Bernard Armani
President and CEO
Eidam Diagnostics Corporation
101-13777 Commerce Parkway
Richmond, BC, V6V 2X3
CRT 2000 Thermographic System
Dear Mr. Armani:
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed information on your internet web site, www.eidam.com, for the CRT 2000 and the CRT 2000® Thermographic Systems. Under section 201(h) of the Food, Drug, and Cosmetic Act (the Act), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
Your Eidam web site contains statements and claims that the devices are intended for use in diagnosis (including primary diagnosis and severity of disease), screening, detection, pre-clinical detection, therapy planning and therapy monitoring of a wide range of diseases, and conditions including: breast cancer, prostate cancer, cardiovascular disorders, heavy-metal toxicity, migraines, chronic fatigue syndrome, low-grade chronic viral and fungal infection, intestinal toxins and dysfunction, immune system weaknesses, lymphatic obstructions, food allergies, rheumatic diseases, and bowel diseases. These statements, claims and information are beyond the scope of the cleared indications for use of the device, which only includes adjunctive use (within the meaning of the words “adjunct” or adjunctive” as explained in the original substantial equivalence order) and does not include comparison of the device output with a library of historical data. In addition, claims that appear on your web site refer to FDA approval for your products. Although FDA cleared a 510(k) for your product for adjunctive detection of temperature changes, FDA has not approved a premarket approval (PMA) application for your product. Marketing your products for these intended uses is a violation of the law. In legal terms, the products are adulterated under section 501(f)1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the devices are safe and effective for the new uses for which you are marketing them or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o) because you did not submit a 510(k) premarket notification to notify the agency of your intent to introduce the devices into commercial distribution for these new uses . For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). 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.
Your devices are also misbranded under 21 CFR 807.97 in that any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.
OC requests that Eidam immediately cease the dissemination of promotional materials for the CRT 2000 and CRT 2000® the same as or similar to those described above. Please submit a written response to this letter within fifteen (15) working days of receipt of this letter, describing your intent to comply with this request, listing all promotional materials for the CRT 2000 and the CRT 2000® the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Debbie Perrell (HFZ-340) at the Food and Drug Administration, 9200 Corporate Blvd., Rockville, Maryland 20850, facsimile at 240-276-0129.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the CRT 2000 and CRT 2000® comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
This page was posted on August 9, 2007.