How do products become FDA approved?


Quick Answer

Products such as human drugs, animal drugs, biological products, complex medical devices, and food and color additives are approved by the U.S. Food and Drug Administration using a variety of methods depending on the product's possible risks. The approval process sometimes involves assessing research data or comparisons with other products.

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Full Answer

The FDA does not directly test the products it approves, but various centers evaluate submitted research before the FDA grants or denies approval. For instance, the Center for Drug Evaluation and Research evaluates evidence from drug company tests to determine if a drug's benefits outweigh its risks. Human drugs first undergo laboratory and animal testing before receiving approval for human testing. Only after tests prove the drug is safe for humans and provides a genuine health benefit does the FDA approve it.

Medical devices undergo different review processes depending upon their classification. FDA premarket approval of high-risk devices such as defibrillators and pacemakers involves assessing evidence from clinical trials conducted by the manufacturer. Secondary devices such as medication pumps and surgical lasers go through a comparison process known as 501(k) premarket notification to prove they are substantially equivalent to devices already on the market. Simple devices such as gauze and stethoscopes do not need FDA approval. Other FDA centers have specific review processes and grades of risk for the products they evaluate.

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