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Device export certificates cost $100 for first country, $10 for additional countries if requested in single letter.

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE EXPORT CERTIFICATE FEE IS $100, the agency announces in a Nov. 6 Federal Register notice establishing export certificate fees for medical devices, drugs, biologics and animal drugs. Subsequent device export certificates issued for the same product(s) in response to the same request cost $10 under the policy, which went into effect Oct. 1.
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