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EXPORT OF UNAPPROVED DEVICES WITHOUT FDA REVIEW NOW PERMITTED UNDER BILL SIGNED INTO LAW APRIL 26; LEGISLATION AUTHORIZES $175 EXPORT CERTIFICATE FEE

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of medical devices and drugs not approved in the U.S. can now export products to any foreign country without prior FDA review as long as the products are approved by any of the industrialized countries specified in the export reform legislation signed into law by President Clinton April 26.
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