The FDA's role is to do testsing on various products and devices for the public's safety and use. It must qualify in the USA (if that's the place invented for/to mass market) before going on to sales elsewhere/internationally.

"The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.

The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.

Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm."

Below is a link to the site's homepage.

http://www.fda.gov/RegulatoryInformation/L...ion/default.htm