Inspections, Compliance, Enforcement, and Criminal Investigations
Non-Invasive Monitoring Systems, Inc. 3/18/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 18, 2011
Marvin A. Sackner, M.D.
CEO and President
Non-Invasive Monitoring Systems, Inc. (NiMS)
4400 Biscayne Boulevard
Miami, Florida 33137
Refer to EC100318 when replying to this letter.
Dear Dr. Sackner:
During an inspection of your firm located in Miami, Florida on March 24, 2010, through March 25, 2010, an investigator from the United States Food and Drug Administration (FDA) learned that your firm is promoting the Exer-Rest in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, the Exer-Rest 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, 21 U.S.C. 321(h). The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your firm’s website (www.nims-inc.com) for the Exer-Rest and has determined that your website promotes the Exer-Rest for uses which you have not obtained marketing approval or clearance, which is a violation of the law.
A review of our records indicates that your product is classified as a therapeutic vibrator, a class I exempt device, when it is intended for relaxing muscles and relieving minor aches and pains. See 21 CFR 890.5975. However, under 21 CFR 890.9, a commercially distributed class I device that is exempt from premarket notification requirements is still required to have appropriate premarket notification before it is introduced or delivered for introduction into interstate commerce when it is “intended for a use different from the intended use of a legally marketed device in that generic type of device.” 21 CFR 890.0(a). You are promoting your device on the website www.nims-inc.com for uses that are different from the intended use of the device as described under 21 CFR 890.5975, but have not provided appropriate premarket notification for such uses. For example, the “Study Support” section of your website indicates that your device may be used during CPR, as “cardioprotective preconditioning,” for brain damage reduction in ischemic strokes, for asphyxia, for enhancing brachial endothelial function, for cardiovascular disease, for asthma, and for fibromyalgia.
For this reason, your device is 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 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). The device 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, 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 C.F.R. 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.
The Office of Compliance requests that NiMS immediately remove these and other like claims from your website and any other promotional or marketing material. 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 for the Exer-Rest with the same or similar claims to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Matthew Kruegerat the Food and Drug Administration, 10903 New Hampshire Avenue, WO66-3676, Silver Spring, Maryland 20993, facsimile at (301) 847-8139. 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 device and its promotional materials comply with each applicable requirement of the Act and FDA implementing regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and