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  1. FDA Basics

Why are animals used for testing medical products?

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Animals are sometimes used in the testing of drugs, vaccines and other biologics, and medical devices, mainly to determine the safety of the medical product.

For drugs and biologics, the focus of animal testing is on the drug’s nature, chemistry, and effects (pharmacology) and on its potential damage to the body (toxicology). Animal testing is used to measure

  • how much of a drug or biologic is absorbed into the blood
  • how a medical product is broken down chemically in the body
  • the toxicity of the product and its breakdown components (metabolites)
  • how quickly the product and its metabolites are excreted from the body

For medical devices, the focus of animal testing is on the device’s ability to function with living tissue without harming the tissue (biocompatibility). Most devices use materials, such as stainless steel or ceramic, that we know are biocompatible with human tissues. In these cases, no animal testing is required. However, some devices with new materials require biocompatibility testing in animals.

There are still many areas where animal testing is necessary and non-animal testing is not yet a scientifically valid and available option. However, FDA has supported efforts to reduce animal testing. In addition, FDA has research and development efforts underway to reduce the need for animal testing and to work toward replacement of animal testing.

When animal testing is done to support applications for medical products regulated by FDA, manufacturers or sponsors are required to follow FDA’s regulation, Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). FDA also supports the use of independent animal care and use committees (IACUC) for laboratory studies involving animals.

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