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"IMPORT FOR EXPORT" PROVISIONS OF EXPORT LAW MAY BE EXPANDED TO INCLUDE UNAPPROVED FINISHED DEVICES; "TRANSSHIPMENT" OF EXPORTS ALSO MAY BE ADDRESSED

This article was originally published in The Gray Sheet

Executive Summary

Congress may expand the "import for export" provisions of "The FDA Export Reform and Enhancement Act of 1996" to allow importation into the U.S. of unapproved finished devices intended for subsequent export, congressional staffers told attendees at a June 27 Food and Drug Law Institute conference in Washington, D.C. The current provisions, which were signed into law April 26, allow manufacturers to import unapproved "components" for assembly of finished devices meant for export.

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