Medical Devices; Export Certificates; FDA Export Reform and Enhancement Act of 1996; Certification Fees

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The Food and Drug Administration (FDA) is announcing the new fees the agency will assess for issuing export certificates for devices. The FDA Export Reform and Enhancement Act of 1996 (EREA) provides that any person who exports a device may request that FDA certify in writing that the exported device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification and that FDA may charge up to $175 for each certification that is issued within the 20 days. FDA's costs to process the device certificates have increased since the inception of the export certification program for devices. Because of the increase, FDA is raising the fees for device export certificates accordingly. This document explains the costs included in the export certification program for devices. This is the first increase of the device export certificate fee under the EREA since the initial fee was established in 1996.