The Food and Drug Administration has provided the following instructions to the import community regarding the submission of entry information for personal protective equipment and certain other medical devices. The FDA states that following these instructions will help facilitate the import process for all, especially goods related to the COVID-19 public health emergency.
Personal protective equipment for general purpose or industrial use (i.e., products not intended for use to prevent disease or illness) is not regulated by the FDA and entry information for these types of products should not be transmitted to the FDA. Instead, importers should transmit entry information to U.S. Customs and Border Protection using an appropriate HTSUS code with (1) no FD flag or (2) an FD1 flag and a ‘disclaim’ for FDA.
For products authorized for emergency use pursuant to an emergency use authorization (click here for current list), entry information should be submitted to the FDA. However, only a reduced amount of FDA information is required for review; i.e., at the time of entry importers should transmit an intended use code of 940.000 (compassionate use/emergency use device) and an appropriate FDA product code.
For products regulated by the FDA as a medical device that are not authorized by an EUA but for which an enforcement discretion policy has been published in guidance, entry information should be submitted to the FDA. To date, guidance documents have been issued for the following products related to COVID-19: face masks and respirators, ventilators and accessories and other respiratory devices, non-invasive remote monitoring devices, and diagnostic tests. At the time of entry, importers should transmit intended use code 081.006 (enforcement discretion per final guidance) and an appropriate FDA product code.
Under both intended use codes listed above, the affirmations of compliance for medical devices (e.g., registration, listing, and pre-market numbers) are optional in the Automated Commercial Environment.
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