Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
Silver Spring, MD 20993
June 1, 2015
2570 Route 9W
Cornwall, NY 12518
Re: Ondamed System
Refer to CMS 444520
Dear Ms. Binder:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Ondamed System in the United States without 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 any function of the body.
As explained below, this device is being marketed without the required clearance or approval in violation of the Act. Our records show that your firm previously (b)(4)
We note that, as part of your (b)(4) FDA provided information to your firm that the Ondamed System is not a biofeedback device under 21 CFR 882.5050.
Your firm has currently registered your establishment and listed the Ondamed System as a biofeedback device under 21 CFR 882.5050. Additionally, FDA has reviewed your firm's website, www.ondamed.net/us, and determined that your firm continues to market the Ondamed system as a biofeedback device. Examples include, but are not limited to:
• "ONDAMED, the Biofeedback System"
• "The ONDAMED Biofeedback therapy uses a unique method palpating the radial pulse while introducing subtle stimulation to the patient's body including auditory and visual signals."
• "ONDAMED: Biofeedback Stimulation to help reduce/resolve stress and stress related health disorders"
The Ondamed System does not fall within the classification regulation for a biofeedback device under 21 CFR 882.5050. As defined by 21 CFR 882.5050, "[a] biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters." The Ondamed System lacks the monitoring functionality that is essential for biofeedback devices; it does not have any design features or capabilities that allow the device to measure, record, or monitor a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
Further, devices classified under 21 CFR 882.5050 (Biofeedback device) are exempt from premarket notification, unless they exceed the limitations on exemption at 21 CFR 882.9. However, there is evidence that the Ondamed System is intended for uses that are different from those legally marketed devices classified under 21 CFR 882.5050 (Biofeedback device). Generic devices of this type are intended for relaxation t raining and muscle reeducation and prescription use. However, your firm is marketing the Ondamed System for different intended uses, including, but not limited to, to treat or cure multiple sclerosis, breast cancer, blindness, Lyme disease, osteoporosis, and for smoking cessation.
Because there is evidence that the Ondamed System is intended for uses different from those of legally marketed devices classified under 21 CFR 882.5050, it exceeds the limitations described in 21 CFR 882.9 and is not exempt from premarket notification.
Therefore, FDA has determined that the Ondamed system is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(8), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g) for the device as described and marketed. The Ondamed System is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for the intended uses discussed above, 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) 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 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.
Our office requests that Ondamed, Inc. immediately cease activities that result in the misbranding or adulteration of the Ondamed System, such as the commercial distribution of the device for the uses discussed above.
Please notify this office in writing within fifteen (15) 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) 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.
Your firm's response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS 444520 when replying. We remind you that only written communication is considered official. If you have any questions about the contents of this letter, please contact: Debra Demeritt, Chief, Surveillance and Enforcement II Branch, Division of Premarket and Labeling Compliance, Office of Compliance, at 301-796-5770 or (fax) 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Jan Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
Kuerzeller Str. 18
Schwanau, AI, Germany 77963
This page was posted on June 11, 2015.