Rx: Just What the Doctor Ordered: International Standards for Medical Devices

Chapman, Mindy H. | January 1, 1994

This Comment demonstrates why the FDA should amend its medical device regulations to emulate those of the European Community. There are two major benefits of a single set of international standards. First, a single set of international standards assures safe medical devices both in the United States and on the international market. Second, the United States will have a greater opportunity to export medical devices to the newly prosperous European Community resulting in greater financial returns and job opportunities for Americans.