Final Rule Allows Imported Device Destruction

Federal Register final rule: FDA is issuing a regulation to implement its authority to destroy a device valued at $2,500 or less that has been refused admission into the U.S. by providing to the owner or consignee a notice and an opportunity to appear and introduce testimony prior to the destruction. The agency says there is currently little deterrence against sellers shipping illegal devices or re-sending previously refused devices to the U.S. through international mail or an express courier. Devices that had been refused admission often were subsequently offered for re-importation by unscrupulous sellers who attempt to circumvent U.S. import regulatory systems. Under the final rule, FDA says it will be better able to deter such shipments by having an administrative mechanism for destroying such devices. To view the notice, click here.