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DEVICE, DRUG EXPORT CERTIFICATE APPLICATION FEES PLANNED BY FDA

This article was originally published in The Gray Sheet

Executive Summary

DEVICE, DRUG EXPORT CERTIFICATE APPLICATION FEES PLANNED BY FDA, according to a compliance policy guide on agency export policy released Sept. 7. FDA says in a same-day Federal Register notice announcing availability of the document that for products such as devices and drugs that fall under its jurisdiction, the agency intends to provide export certification "with the anticipation of achieving full cost recovery by charging the requester a fee based on the actual expenses incurred." The agency says it will carry out export certification services "either itself or by third parties under FDA oversight."

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