Administrative Destruction
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, Agency, or we) is issuing a regulation to implement our authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. We are finalizing the change to our internal procedures for administrative destruction of drugs and devices. The notice of proposed rule making (NPRM) published in the Federal Register (October 7, 2022).
Abstract as published in the Federal Register.
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