Dzebovskaya, Yelena d/b/a Matrix Health Line 11/8/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
NOV 8, 2012
VIA UNITED PARCEL SERVICE
Matrix Health Line
120 Oceana Drive West, Ph 4
Brooklyn, New York 11235
Re: Cem-Tech Millimeter Wave Therapy devices (Cem-Tech, Cem-Tech Mini & Cem‑Tech with 30 EHF)
Refer to CPT1200448 when replying to this letter
Dear Mr. Pizhadze:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Cem‑Tech Millimeter Wave Therapy (MMV) devices in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed your websites, www.matrixhealthline.com and www.cemworldusa.com, on October 5, 2012, for the MMV devices. These products are devices within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), 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 to affect the structure or function of the body.
The information on your firm’s websites state that the Cem-Tech MMV devices can be used to treat kidney diseases, cardiac insufficiency, sexual disorders, and visual acuity loss.
Additionally your websites state that the Cem-Tech MMV devices have undergone testing for a number of years in Russia and that the results have shown that the devices can be used to cleanse the body and organs of heavy metals, viruses, bacteria, parasites, infections, candida, and other maladies; to normalize the parameters of the immune system; to reduce the risk of illness with oncological disease; and to reduce healing time for stroke and brain hemorrhages.
In light of these claims, the Cem-Tech MMV devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.§ 351(f)(1)(B), because your firm does not have an approved application for premarket approval (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). The devices are 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 devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance of 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.
Your firm should take prompt action to correct the violations addressed in this letter, and stop further distribution until clearance or approval is attained. 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.
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, as well as 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 (including any systemic corrective actions) 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.
Please direct your response to Tanisha Hithe at the Food and Drug Administration, White Oak Building 66, Rm 3560, 10903 New Hampshire Ave., Silver Spring, MD 20993, facsimile at 301-847-8138. We remind you that only written communications are considered official.
Finally, you should know that this letter is not intended to be an all-inclusive list of your firm’s violations. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring your firm’s products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and