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U.S. Department of Health and Human Services

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Enforcement Actions

Quantum Devices, Inc. 7/11/12

  

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 

 

July 11, 2012
WARNING LETTER
 
 
VIA UPS EXPRESS
 
Mr. Glenn R. Ignatius
President
Quantum Devices, Inc.
112 E. Orbison Street
Barneveld, Wisconsin 53507
 
Dear Mr. Ignatius:
 
The Food and Drug Administration (FDA) has learned that your firm is marketing the WARP 10 and WARP 75 LED Light Delivery System (respectively, Warp 10 and Warp 75) devices in the United States without appropriate marketing approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act). 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 the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
 
Your firm obtained clearance of the WARP 10 (K032229) on November 3, 2003, and the WARP 75 (K113231) on February 27, 2012, under section 510(k) of the Act, 21 U.S.C. § 360(k).  Both the WARP 10 and WARP 75 devices are cleared for over-the-counter use for the following indications: “for the treatment of chronic pain by emitting energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; to temporarily increase local blood circulation where applied.”
 
The Office of Compliance, in the Center for Devices and Radiological Health, reviewed your firm’s website, www.qbmi.com (formerly www.warp-photomedicine.com), and found that your firm is making claims for these devices that represent major changes or modifications in their intended uses.  Examples include, but are not limited to:
 
  •  “For use in the treatment of mucositis in cancer patients.”
  • “For pain management, accelerated wound healing, improvement in blood properties, and since –related [sic] diseases and disorders.”
  • “Relief of pain from joint and muscle strains.”
  • “Relief of pain from joint inflammation.”
 
Based on these changes in intended use, the WARP 10 and WARP 75 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).  These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution with the changes described above, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For devices 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 for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether these devices may be legally marketed.
 
The Office of Compliance requests that Quantum Devices immediately cease marketing the WARP 10 and WARP 75 devices for unapproved uses such as those described above.  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.
 
Your firm’s response should refer to the Unique Identification Number 310758 and be sent to:  
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
White Oak Building 66, Rm 2609,
10903 New Hampshire Ave.
Silver Spring, MD 20993 
 
If you have any questions about the contents of this letter, please contact: Matthew Krueger, Chief, Orthopedic and Physical Medicine Devices Branch at 301-796-5585 or by fax at 301-847-8139.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  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 the products into compliance.   
 
 
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
 Radiological Health