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Regulation

23 - 08 - 2018

Why are medical products tested on animals? A note from the FDA

The US Food and Drug Administration (FDA) updated its information page on the regulatory use of animals for the evaluation of medical products on August 22.
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Animals are in some cases used to evaluate drugs, vaccines, biological products or medical devices. It is a scientific and health necessity and a regulatory constraint.

Concerning drugs, vaccines and biological products, the objective is to evaluate their passage in the blood, their degradation and then their excretion by the organism as well as their toxicity.

With regard to medical devices, the objective of animal testing is to verify the proper functioning of the device in contact with living tissue and the absence of harmful effect (biocompatibility).

When a device is composed of materials with good known biocompatibility with human tissues (stainless steel, ceramic) no animal testing is performed. This is not the case in the presence of new materials.

The FDA recalls that Good Laboratory Practices (GLP) are mandatory for all establishments that perform animal testing within the regulatory framework. These GLPs incorporate many requirements regarding the conditions of accommodation and use of animals. Rigorous inspections are conducted. Non-compliance with GLP may lead to the refusal of the study or the disqualification of the establishment. This is also the case in Europe.

 

https://www.fda.gov/about-fda/fda-basics/why-are-animals-used-testing-medical-products

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000158.jsp&mid=WC0b01ac05800268ae