RETURN RECEIPT REQUESTED
November 19, 2004
Mr. Greg Robinson
Chief Executive of Operations
USA Biomed Corporation
2881 Valley View
Las Vegas, NV 89102
Dear Mr. Robinson:
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.usabiomed.com for the B-Safe HIV/AIDS 1 & 2 Personal and Private Screening Device. Your website promotes your screening device as a chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) Types 1 and 2 in human serum, plasma or whole 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. Your website states " . . . right now our screening device is not approved by the U.S. FDA, even though it is approved by the FDA in other countries and used world wide in hospitals, clinics, laboratories and point of care facilities. Sort of makes you wonder why the U.S. doesn't approve the device." You have never submitted an application for your product for FDA review. Furthermore, the statement that your product is "approved by the FDA in other countries" is false and misleading in that the United States FDA does not "approve" products for use in other countries.
The Internet website above fails to state that the B-Safe HIV/AIDS 1 & 2 Personal and Private Screening Device is not for sale in the United States. Instead, your website appears to promote the B-Safe device to buyers in the United States. Your website includes statements such as "Click on a button below to view our products available for purchase" and "B- Safe Personal and Private Screening Device . . . $19.95 + S & H." 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, the unapproved B-Safe HIV/AIDS 1 & 2 Personal and Private 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.
The B-Safe HIV/AIDS 1 & 2 Personal and Private 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 Flynn at (301) 827-6201.
----- signature -----
James S. Cohen, J.D.
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc: Tucows Inc
96 Mowat Avenue
Toronto, Ontario M6K 3M1