The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) is coordinated through the Department of Essential Medicines and Health Products (EMP). Focus is placed on in vitro diagnostics for priority diseases and their suitability for use in resource-limited settings.
CE Marking is the symbol as shown on the top of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”. The term initially used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993. “CE Marking” is now used in all EU official documents.
The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item’s planned use.