What Does FDA Approved Mean

The FDA or the United States Food and Drug Administration is the federal level government agency whose mission it is to ensure 1) the safety of the nation’s food supply, cosmetics and radiation-emitting products; and 2) the safety, efficacy and security of drugs for both humans and animals, medical devices and biological products.

The FDA also regulates the manufacturing, distribution and marketing of tobacco products in an effort to protect public health and reduce tobacco use by minors. The agency is further tasked to speed innovations that make medical products safer, more effective and affordable. By promoting the development of medical products, including drug testing kits, the public is able to respond more effectively to emerging threats both natural and deliberate, to public health.

What Does the Term “FDA Approved” Mean in the Drug Testing Industry?

FDA regulations are highly stringent, with very thorough inspections and stiff penalties for non-compliance. The drug testing industry closely adheres to FDA regulations, and getting an FDA approval stamp on drug test kits mean that these devices have undergone and passed scientific processes to prove their safety, validity and accuracy. These scientific processes include clinical trials, extensive documentation and verification. They also include FDA inspection of facilities and laboratories.

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