CBP Clarifies FDA Entry Requirements for Emergency Imports to Address COVID-19 Pandemic
Importers of some N95 respirators and COVID-19 diagnostic tests that have been authorized pursuant to a Food and Drug Administration Emergency Use Authorization (EUA) must still submit a reduced entry dataset to FDA, CBP said in a recent CSMS message. For product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies), as well as product codes QPK, OTG, QKO, and QJR (various forms of diagnostic tests for COVID-19), importers must transmit an intended use code of 940.000 (Compassionate Use/Emergency Use) and an appropriate FDA product code, CBP said.
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Entry information must also be submitted to FDA for certain products regulated by FDA as devices, and not authorized by an EUA, but where an enforcement discretion policy has been published in guidance, CBP said. These include non-invasive remote monitoring devices and ventilators and other respiratory devices. For these products, FDA requires “an Intended Use Code of 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code.”
On the other hand, entry information should not be transmitted to FDA for personal protective equipment for general purpose or industrial use. These products, not intended for use to prevent disease or illness, are regulated by FDA. Filers of entries of such products should transmit entry information to CBP “using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA,” CBP said.