HIV Home Test Kits

FDA Approved - The only U.S. Food and Drug Administration approved HIV-1 test system
The Home Access® Express HIV-1 Test System
The Home Access® HIV-1 Test System
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Wednesday, February 09, 2005

What does "FDA Approved" mean?

HomeAccess® HIV Test Kit - The only U.S. FDA Approved HIV-1 test system
The United States Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the American public through the regulation of food, drugs and medical devices, among other responsibilities.

It is probably the most critical mission assigned to any of our federal governmental agencies and, as you can imagine, the FDA takes its oversight mission seriously. Its regulations are extremely stringent. Its inspections are thorough. Its penalties for non-compliance are damaging. But when you are talking about food, drugs and medical devices, you wouldn't want it any other way, would you?

All products marketed by Home Access Health Corp. are considered medical devices. Medical devices generally are subject to the most stringent regulations administered by FDA.

When we say that Home Access at-home tests are FDA-Approved, it means that EVERY aspect or component of our test system, including any claim found on our kit boxes, has been scientifically proven to be valid, safe and effective. This involves extensive clinical trials with hundreds of patients, backed up by voluminous documentation and verification of the clinical trail results. It also includes a thorough FDA inspection of our laboratory and facilities in addition to intense review of the validity of our computer system's hardware and software.

It is against the law for any product or service to claim it is FDA-Approved when it isn't. And when a product isn't FDA-Approved it means that FDA hasn't been afforded the opportunity to review or pass judgment on any data or science connected to a specific product's claims. This could also mean that there ISN'T any science or data available to back up a specific product's claims. There is no reason to risk your money or your health with unregulated products. You could very well be buying something that may or may not work, or at the very least, may or may not provide what the box or advertisement says it does. Caveat Emptor (Buyer Beware).

For medical devices, being FDA-Approved is an extremely important consideration for consumers and not to be taken lightly.

HomeAccess® HIV Test Kit - The only U.S. FDA Approved HIV-1 test system