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FDA Approved! – What is it? Pt 1

It is not uncommon for people to take notice on product labels, company websites, commercials promoting a new product or treatment or hear some marketers saying the word’s “FDA approved!” What does that even mean and is it really FDA approved? How can you know for sure what the US Food and Drug Administration approves?

The FDA is responsible for protecting public health. This is done by regulating the following:

  • human drugs and biologics,
  • animal drugs,
  • medical devices,
  • tobacco products,
  • food (including animal food),
  • cosmetics and
  • electronic products that give off radiation

That being said not all these products undergo premarket approval. Basically, premarket approval is a review of safety and effectiveness done by FDA experts. A successful review results in agency approval before a product can be marketed. However, in some cases FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. So even when the FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

This article and subsequent articles will look at how the FDA regulates products and what it does and doesn’t approve.

FDA does not approve companies

The foremost things to note with regards to FDA approval is that it doesn’t approve healthcare facilities, laboratories or manufacturers. However, the agency has authority to inspect regulated facilities. The inspection is done to verify that the facilities comply with applicable good manufacturing and practice regulations.

The owners and operators of domestic or foreign food, drug and most device facilities must register with the FDA. Such facilities may not be registered only if an exemption applies. Blood and tissue facilities also must register with the FDA.

Other facilities require certification by the FDA. For example, mammography facilities must receive certification from the FDA and display their certificates. Such certification shows that facilities have met the strict standards for providing quality mammography.



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