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Health Law and Policy

Northwestern Pritzker School of Law

1994

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Rx: Just What The Doctor Ordered: International Standards For Medical Devices, Mindy H. Chapman Jan 1994

Rx: Just What The Doctor Ordered: International Standards For Medical Devices, Mindy H. Chapman

Northwestern Journal of International Law & Business

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.