UPS EXPRESS MAIL
To the Registrant of www.std-tests-r-us.com
Contact Privacy, Inc. Customer 0129482383
c/o Tucows, Inc.
96 Mowat Avenue
Toronto, ON M6K 3M1
To Whom It May Concern:
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (FDA) has reviewed your Internet website http://www.std-tests-r-us.com. Your website promotes the HIV At Home Test and the Oral Home HIV Test as tests that detect the presence of HIV-1 and HIV-2 antibodies in blood and oral samples respectively. 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 (the 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 (IDE) under section 520(g). These statutory provisions protect the public health and ensure that new medical devices are safe and effective.
The devices promoted on your Internet website are not approved for sale in the United States and have not received investigational device exemptions from premarket approval. The Internet website above does not exclude the sale of the HIV test kits in the United States. Instead, your website appears to promote the HIV At Home Test and the Oral Home HIV Test to buyers in the United States. For example, your website sells the device in U.S. dollars. Moreover, the United States is included in the “drop-down” box on the payment page, inviting orders for shipment of the product within the United States. Further, your website states “. . .we only ship within the United States currently.”
If you introduce, or deliver for introduction, the HIV At Home Test or the Oral Home HIV Test into interstate commerce in the United States, you would be distributing adulterated devices in violation of sections 301(a) and 501(f)(1)(B) of the Act.
Additionally, product labeling that is false or 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 about the HIV At Home Test and the Oral Home HIV Test on your Internet website. For example, you state:
“Laboratory accurate;” and
“Over 92% accuracy.”
The HIV At Home Test and the Oral Home HIV Test may not be legally marketed in the United States absent premarket approvals or IDEs. You should take prompt action to correct the violations referenced above. To avoid violating the Act, you must refrain from introducing the products into U.S. interstate commerce, and refrain from delivering the products for introduction into U.S. interstate commerce, until premarket approvals or IDEs for the devices have been obtained, and your devices otherwise comply fully with the Act.
If you have any questions regarding this matter, you may contact Anna M. Flynn at (240) 402-9155. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research