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FDA DEVICE EXPORT APPROVAL PROGRAM BASED ON FOREIGN GOVERNMENT CLEARANCE

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE EXPORT APPROVAL PROGRAM BASED ON FOREIGN GOVERNMENT CLEARANCE could be accomplished through administrative changes rather than amendments to device export law, Marlene Tandy, Health Industry Manufacturers Association director and counsel for technology and regulatory affairs, asserted May 18 at a Food and Drug Law Institute seminar.
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