Public Health Service Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
May 12, 2014
Via United Parcel Service
David Gane, DDS
President and CEO
LED Medical Diagnostics, Inc.
LED Dental, Inc.
5589 Byrne Road, Suite 235
Burnaby British Columbia
V5J 3J1 Canada
Re: VELscope Vx
Refer to CMS # 423575
Dear Dr. Gane:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the VELscope Vx device 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 to affect the structure or any function of the body.
The FDA has reviewed your firm’s website at www.leddental.com and determined that the VELscope Vx is 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) for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced this device or delivered it for introduction into interstate commerce with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the VELscope Vx was cleared under K102083 with the following indications for use: VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that many not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. Also, VELscope Vx is intended to be used by a surgeon to help identify diseased tissue around a clinically-apparent lesion and thus aid in determining the appropriate margin for surgical excision. However, your firm’s promotion of the device provides evidence that your firm is marketing it for early detection of oral mucosal abnormalities,which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include:
“Detecting oral abnormalities early leads to more treatment options, potentially less invasive or radical treatments and better patient outcomes”
“Introducing the VELscope Vx Enhanced Oral Assessment System, which centers on a wireless, handheld scope that applies tissue fluorescence visualization to identify oral mucosal abnormalities early – often months or even years before they can be identified with the unassisted eye”
“Cleared by FDA, Health Canada, and the World Health Organization, the winning VELscope Vx is the world’s most widely used adjunctive device for the discovery of Viral, fungal and bacterial infections; inflammation from a variety of causes (lichen planus and licheniod reactions, allergy to amalgam fillings, etc); Squamous papillomas; Salivary gland tumors; Cancer and pre-cancer; Other oral mucosal conditions.”
“The VELscope Vx, the latest model release of VELscope technology, uses natural tissue fluorescence to discover abnormalities in the oral mucosa”
“The VELscope Vx system enchances the way practitioners examine the oral mucosa and screen for tissue abnormalities, potentially leading to the earlier discovery of pre-cancer, cancer or other disease processes.”
“Early detection is one of the best mechanisms for enabling treatment success, increasing survival rates and maintaining a high quality of life.”
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 LED Dental, Inc., immediately cease activities that result in the misbranding or adulteration of the VELscope Vx, such as the commercial distribution of the device for the uses discussed above.
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 (which must address systemic problems) 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 Inspection Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS # 423575 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Debra Demeritt,Chief, Surveillance and Enforcement Branch II 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.