FDA Proposes to Require PGA Message Set Filing in ACE for Veterinary Devices
FDA is proposing changes to its regulations that would require electronic filing in ACE of partner government agency (PGA) data for veterinary devices. The agency’s proposed rule would require filers of entries of veterinary devices to transmit the (1) FDA…
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Country of Production; (2) complete FDA Product Code; (3) full intended use code; (4) and telephone number and email address of the importer of record. “These data elements are currently required to be submitted for the electronic filing of entries containing food contact substances, drugs, biological products, [human cells, tissues or cellular- or tissue-based products (HCT/Ps)], medical devices for human use, radiation-emitting electronic products, cosmetics, and tobacco products,” FDA said. Comments are due Oct. 18.