FDA Issues Final Rule on Administrative Destruction

Posted by Sila Barr on 6/17/24 5:00 PM

On May 31, 2024, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register establishing a regulation to authorize the agency to "administratively destroy" devices that have been refused admission into the U.S. 

The authorization will apply to devices $2,500 or less, and will provide "the owner or consignee notice and an opportunity to appear and introduce testimony prior to destruction." 

The rule is effective on July 1, 2024. 

The final rule can be found here:

Topics: FDA, admissibility

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