PGA Filing Exemption for Some De Minimis FDA Products Ends, 'Effective Immediately'
Several FDA-regulated products previously exempt from partner government agency filing requirements when falling under the $800 de minimis threshold must now be reported to the FDA, “effective immediately,” CBP said in a cargo systems message issued July 9.
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Since 1994, cosmetics, dinnerware, radiation-emitting non-medical devices, biological samples for laboratory testing and most foods could be released by CBP without filing an entry with FDA data. In recent years, that has meant they haven’t required a Type 86 entry in order to obtain de minimis treatment.
But “technological capabilities of both the trade and the FDA have advanced significantly,” the message said. “Effective immediately, all FDA-regulated products must be submitted to the FDA for review. All prior communications exempting certain low-value FDA-regulated products are rescinded.”