Customs Updates: Filing PPE and Medical Devices During COVID-19

Information provided by US Customs.

The U.S. Food and Drug Administration (FDA) has provided updates to the instructions for the submission of entry import information for personal protective equipment and other devices focusing on products related to the COVID-19 public health emergency.

The updates fell under the following classifications;

Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.)

Entry for these items should not be transmitted to the FDA but to US Customs and

Border Protection using the appropriate HTS code with either no FD Flag or an FD1

flag and a ‘disclaim’ for FDA.

Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)

Imports of these products are to be submitted to the FDA but reduced information is

required for review. Upon entry Importers are to transmit an Intended Use Code of

940.000: Compassionate Use/Emergency Use Device, alongside the appropriate FDA

product code. A list of products and the appropriate product codes as authorized

under the EUA can be found here.

Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

Entry information for such devices should be submitted to FDA. At the time of entry,

Importers should transmit Intended Use Code 081.006: Enforcement discretion per

final guidance, alongside the appropriate FDA product code. The FDA has also

compiled a full list of guidance documents for product codes and policies around

COVID-19 related transactions which can be found here.

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