FDA Guidance on Importing KN95 or N95 Masks

2020-04-08 / 208 views

The U.S. Food and Drug Administration (FDA) is now offering guidance for KN95 masks, which are a Chinese-equivalent of N95 masks. Moreover, increased licensing on Chinese exports of medical supplies is now required and highly regulated by the Chinese Government.

FDA Guidance on KN95 Masks

There are rumors that several delays and/or FDA refusals of KN95 mask shipments are occurring. KN95 masks are an equivalent Chinese-alternative to the scarce N95 masks.

FDA is using the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies information to expand access, which includes KN95s.

KN95, KN100, KP100, and KP95 Filtering Facepiece Respirators (Standard GB 2626-2006) NOT Under EUA.

CDC's Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies 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 Guidance on Importing KN95 or N95 Masks Blog

ACE Transmission Requirements for KN95s KN100, KP100, and KP95 NOT under EUA:

Program Code: DEV
Processing Code: NED
Intended Use Code: 940.000 if the product is listed on the CDC website
081.001 if not listed on the CDC website
Product Code: 80N-ZJ
Use the Product Classification and Product Code Builder

U.S. Customs and Border and Protection (CBP) has established a COVID-19 Cargo Resolution Team (CCRT) as an effort to coordinate inquiries regarding the importation of medical supplies and personal protective equipment. The team is multidisciplinary to triage incoming inquiries, coordinate with affected ports and respond directly as appropriate.

To assist your U.S. Customs broker or CBP in expediting the release of COVID-19 relief materials, please include as much data about the shipment as possible. Ideally, this will include the following:

Shipment information: manifest or air waybill numbers, tracking numbers. entry numbers, mode of transport information
Conveyance information: carrier name, mode of transportation, flight number, vessel/voyage number, port of arrival, port of entry
Cargo description: complete description or the goods being shipped
Country information: country of manufacture, country of export
Parties involved: names and locations of manufacturers, shippers, importers, and consignee