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FDA Export Rule Imposes Paperwork Burdens On Manufacturers, HIMA Says

This article was originally published in The Gray Sheet

Executive Summary

Labeling claims and product specifications on package inserts are sufficient to demonstrate that a device meets a foreign purchaser's specifications, making documentation required in FDA's April 2 proposed rule implementing the Export Reform and Enhancement Act of 1996 unnecessary, the Health Industry Manufacturers Association asserts in July 7 comments to the agency.
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