Vaccines, Blood & Biologics
HIV Home Test Kit
(Sunrise Valley Holdings, Ltd)
August 15, 2006
Sunrise Valley Holdings, Ltd.
24 De Castro Street
Wickams Cay I
Road Town, Tortola
To Whom It May Concern:
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the Food and Drug Administration (FDA) has reviewed your Internet website http://www.testhivnow.com. Your website promotes your screening device as a rapid home test to determine the presence of Human Immunodeficiency Viruses (HIV) in human blood. Copies of the pertinent Internet website pages are enclosed for your reference.
HIV test kits are medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act) because they are in vitro diagnostic instruments intended for use in the diagnosis of disease. Under section 513(f) of the Act, the devices are class III devices, which under section 501(f)(1)(B) are deemed to be adulterated unless they have received premarket approval under section 515 or an investigational device exemption under section 520(g). These statutory provisions protect the public health and ensure that new medical devices are safe and effective.
The device promoted on your Internet website is not approved in the United States and has not received an investigational device exemption from premarket approval. Further, you have never submitted an application for your product for FDA review.
The Internet website above does not exclude the sale of your HIV screening device in the United States. Instead, your website appears to promote your HIV screening device to buyers in the United States. Your website includes statements such as "HIV Home Test Kit $19.95;" "Delivery via express courier arrives in approximately 1-3 weeks worldwide;" "Pricing in US Dollars." Moreover, the United States is included in the "drop-down" box on the payment page, inviting orders for shipment within the United States.
If you introduce, or deliver for introduction, your unapproved HIV screening device into interstate commerce in the United States, you would be distributing an adulterated device in violation of sections 301(a) and 501(f)(1)(B) of the Act.
Product labeling that is false and misleading in any particular renders a device misbranded under section 502(a) of the Act. If you introduce, or deliver for introduction, a misbranded device into interstate commerce in the United States, you would be doing so in violation of sections 301(a) and 502(a) of the Act. We are concerned about the accuracy of some of the statements on your Internet website. For example, you state:
- "Tests 99.98% accuracy;"
- "Rapid tests in 10-15 minutes;" and
- "The self rapid tests we manufacture are just as accurate as the expensive USFDA approved tests . . ."
Your HIV screening device may not be legally marketed in the United States. To avoid violating the Act, you must refrain from introducing your product into U.S. interstate commerce, and refrain from delivering your product for introduction into U.S. interstate commerce.
If you have any questions regarding this matter, you may contact Ms. Anna M. Flynn at (301) 827-6201. Please be advised that only written communications are considered official.
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Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Internet website pages from http://www.testhivnow.com