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.
Mindy H. Chapman,
Rx: Just What the Doctor Ordered: International Standards for Medical Devices,
Nw. J. Int'l L. & Bus.