FDA to Require PGA Message Set Filing in ACE for Veterinary Devices
FDA is finalizing changes to its regulations that require electronic filing in ACE of PGA data for veterinary devices. The agency’s final rule requires filers of entries of veterinary devices to transmit the (1) FDA Country of Production; (2) complete…
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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 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. The final rule takes effect Nov. 17.