What does "FDA Approved" mean?

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? When we say that the test kit is FDA-Approved, it means that EVERY aspect or component of the 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 the laboratory and facilities in addition to intense review of the validity of the 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.

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What does "FDA Approved" mean?

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