With the Coronavirus upon us, global demand for supplies used to treat and help protect people, such as face masks and respirators, is currently exceeding supply. Fortunately, many manufacturers around the world have ramped up production to help get supplies where they are most needed.

Importing these products is not simple! Here’s what you need to know:

  • Personal protective equipment for general purpose or industrial use (in other words, products that are not intended for use to prevent disease or illness) is not regulated by FDA. For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (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.
  • Respirators and masks that are intended for non-medical purposes are regulated under the Occupational Safety and Health Administration (OSHA).
  • Respirators and masks that are intended for medical purposes are a medical device and are regulated by the FDA.
  • In order to import a medical device and products that emit radiation into the U.S., foreign manufacturers must meet applicable United States (U.S.) medical device regulatory requirements, even if the product is authorized for marketing in another country. Some of the requirements include Registration and Listing, manufacturing in accordance with the Quality System Regulation(QSR), medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval.
  • Per the Who Must Register, List and Pay the Fee webpage, all establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S are required to register annually with the FDA. This includes the initial importer, the foreign exporter and the manufacturer, as applicable.
  • Additionally, foreign manufacturers must designate a United States Agent, and all medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection(CBP) requirements.
  • With a surge in demand due to the COVID-19 outbreak, the FDA has been facilitating the import of surgical masks, N95 respirator and any protective gear for medical professionals. When importing products authorized for emergency use pursuant to an Emergency Use Authorization (EUA), importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use, and the appropriate product code that is currently authorized by an EUA for masks/respirators is NZJ.
  • Firms who have applied for and received approval for specific products under an EUA are entitled to reporting of reduced FDA information when reporting Intended Use Code 940.000 (Compassionate Use/Emergency Use) and an appropriate FDA product code specific to pre-approved product.
  • Be mindful that we are hearing reports of delays and refusals by FDA of KN95 mask shipments. KN95 masks are an equivalent Chinese-alternative to the scarce N95 mask. The following information should help in getting clearance for these items:
    • FDA is using the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies information to expand access, which includes KN95s. The link provides instructions on the entry process for KN95s, KN100s, KP100s, and KP95 Filtering Facepiece Respirators (Standard BG 2626-2006 NOT Under EUA).  It identifies respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators. CDC has determined these are suitable alternatives to provide protection during the COVID-19 response when supplies are short, when they conform to standards identified and provide a protection factor of at least 10. FDA does not object to importation and use of these respirators during the emergency.
    • FDA cannot confirm the performance and quality of face masks and respirators not under an EUA. The only person who can verify the authenticity is whoever issued it.
  • ACE Transmission Requirements for KN95s KN100, KP100, and KP95 NOT under EUA are as follows:
  • When importing products regulated by the FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance, it would temporarily qualify for special discretionary handling by the FDA. At the time of entry, importers should transmit intended use code 081.006: Enforcement discretion per final guidance, and appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
  • A list of respirators eligible for Emergency Use Authorization (EUA) is available in Appendix A and a list of respirators authorized under the EUA is available in Appendix B of the EUA’s letter of authorization.
  • Requests for Emergency Use Authorization for diagnostic devices can be submitted to FDA at: [email protected]. Request for emergency authorization for non-diagnostic devices can be submitted to the FDA at: [email protected].
  • If you are importing textile face masks without a replaceable filter or mechanical parts, including surgical masks and disposable facemasks made of non-woven textiles, the applicable subheading is 6307.90.9889 and the general rate of duty is 7% ad valorem.
  • Recently, the USTR granted exemption from tariffs for a range of Section 301, List 4A medical products imported from China, including face masks, for single use, of textile fabrics. The exclusion eliminates 7.5% additional tariffs until September 1, 2020. A complete list of the announced exclusions involving medical products can be found here.
  • For more information about face masks and N95 respirators regulated by the FDA, please visit the Masks and N95 Respirators
  • For more information about US regulatory requirements for medical devices and radiation-emitting products, please visit the Overview of Device Regulation and the General Controls for Medical Devices

Please visit our Regulatory Compliance service page or reach out to [email protected] with any questions or for any assistance with the FDA process.

Additional Resources: