Why are medical treatments approved in other countries but not the US?

Sometimes a medication or device that is not approved by the U.S. Food and Drug Administration (FDA) will be available in Europe or other parts of the world. This does not necessarily mean the device or medication is unsafe.

For a device to be used in Europe it must have CE Marking. The letters "CE" are the abbreviation of the French phrase "Conformité Européene," which means "European Conformity."  A CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

Approval studies, often called clinical trials, are required for approval of a drug or device in all parts of the world. Different regulatory requirements in individual countries can lead to approval in certain countries prior to other countries.