When is GLP-compliant testing recommended?

GLP-compliant testing is recommended when seeking approval of medical devices in the U.S. market (or in markets aligned with the U.S. FDA). The U.S. Food and Drug Administration (FDA) favors testing that is GLP compliant. GLP-compliant trials offer stringent quality controls and comprehensive documentation, which can facilitate their acceptance by the FDA.

The decision whether to conduct GLP-compliant or non-GLP-compliant testing is highly dependent on the market in which the products are to be approved.