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Most Device Exporters Can Self-Certify
Exporters of devices, pharmaceuticals and biologics that are legally marketed in the U.S., are not approved in the U.S. but acceptable to the importing country, or conform to World Health Organization format may continue to self-certify to receive FDA export approval, the agency says. Comments on the FDA notice are due April 2.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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