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U.S. Department of Health and Human Services

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Enforcement Actions

NeuroMed Devices, Inc. 10/22/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

OCT 22, 2012

WARNING LETTER


Via United Parcel Service

Leon Silverstone, M.D.
President and Chairman
NeuroMed Devices, Inc.
5348 Vegas Drive, Suite 782
Las Vegas, Nevada 89108

Refer to GEN1000690 when replying to this letter.

Dear Dr. Silverstone:

The Food and Drug Administration (FDA) has learned that your firm is marketing the ViraCalm and OraCalm products in the United States.  These products are devices within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C.§ 321(h), because they are intended for use in the diagnosis of disease or other conditions or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.  As explained below, these devices are being marketed without the required clearance or approval in violation of the Act.

Your firm obtained clearance of the Neuro Calm Transcutaneous Electrical Nerve Stimulator (TENS) Device (Model 1 corresponding to the ViraCalm and Model 2 to the OraCalm device) under section 510(k) of the Act, 21 U.S.C. § 360(k) [K090866], for the following indications:

“The NeuroCalm TENS Device is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.”  Further, these devices were cleared for prescription use only. 

The Office of Compliance in FDA’s Center for Devices and Radiological Health reviewed your firm’s website, www.neuromed-devices.com, on August 31, 2012, and found the following claims for the ViraCalm and OraCalm devices:

• “The No side Effects Remedy.  Stop Herpes right at the outbreak!”
• “NeuroMed Devices Inc. has been leading the way in helping overcome this deadly disease. The development of breakthrough devices, OraCalm and ViraCalm, made using our pioneering non-invasive neuromodulation technology, is primarily aimed at treating Oral herpes [sic] and Genital Herpes at the site of the outbreak.”
• “NeuroMed Devices Inc. is committed in our efforts to help overcome Herpes. Herpes need not hinder your chance to lead a full life.  Learn about our breakthrough devices OraCalm® and ViraCalm® lead an enjoyable, healthy life.”

We also note that the webpage: http://www.neuromed-devices.com/content/viracalm-and-genital-herpes/neonatal-herpes/index.html contains statements about the treatment of genital herpes in pregnant women.  For example:

•  “THUS, USE OF THE NON-INVASIVE DEVICE TO TREAT GENITAL HERPES IN A PREGNANT FEMALE PRIOR TO DELIVERY COULD PREVENT BLINDNESS, BRAIN DAMAGE OR EVEN DEATH OF THE NEWBORN.”

During the course of the review of the 510(k) for the NeuroMed device, your firm was asked to revise the names given to the two models of the device (OraCalm and ViraCalm) in order to remove any implied reference to the treatment of herpes.  In a 510(k) supplement dated September 9, 2009, your firm agreed and changed the product name to Neuro Calm.  Your firm was also asked to remove all references to the treatment of oral and genital herpes from its products’ indications for use. 

Promoting the ViraCalm and OraCalm devices for treating or allowing someone to overcome herpes represents a major change in the intended use of the devices that could affect their safety and effectiveness.  Therefore, the ViraCalm  and OraCalm 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. § 360(e)(a), or an approved application for an investigational device exemption (IDE) under section 520(b) of the Act, 21 U.S.C. § 360j(g).  The ViraCalm and OraCalm 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 device into commercial distribution for the new intended use as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(ii). 

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 its device is described on the Internet at  http://www.fda.gov/cdrh/devadvice/3122.html.

The Office of Compliance requests that NeuroMed Devices, Inc., immediately cease making claims that are the same as or similar to claims addressed in this letter.  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 that 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:

Ms. Toni Stifano
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
Silver Spring, MD 20993

Finally, you should know that the violations discussed in this letter do not necessarily constitute and exhaustive list.  It is your firm’s responsibility to ensure compliance with each applicable requirement of the Act and FDA implementing regulations. 
 

Sincerely yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health