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What are the FDA requirements for exporting unapproved medical devices for investigational use?
A manufacturer who wishes to export an unapproved device for investigational use may export the device under an Investigational Device Exemption (IDE), under section 801(e)(2), or under 802(c) of the act depending on which country the device is being exported.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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