Import KN95 and Face Mask into USA

This content is for public only. All links below are from FDA or CDC official website.

These suggestions are not from AMJOY (PPAI#508991) and the related websites.

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Thank you for your inquiry. We are receiving a large number of emails in this inbox, and we will respond to your email as quickly as we can. For the latest guidance you can view this page: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19. FDA will also continue to push information to the import community via U.S. Customs and Border Protection CSMS messaging.

Below is some general information that may help answer your question while awaiting a response to your inquiry. Please see Importing COVID-19 Supplies.

FDA does not issue licenses or permits to import.  Some firms may be subject to registration and listing, but these requirements have been waived for many of the products below during the public health emergency.  Please see the specific product information in the applicable Emergency Use Authorizations or Enforcement Policies.

Please see FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) for a full list of information that must be transmitted to FDA, including mandatory/conditional/optional affirmations of compliance.

 General Purpose Protective Equipment

Personal protective equipment for general purpose or industrial use, including NIOSH-certified N95 respirators (not intended for use to prevent disease or illness) are not typically regulated by FDA. Products not regulated by FDA should not be transmitted to FDA and/or should be disclaimed.

Face Masks and Respirators

Newly Revised 4/2/2020Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.

General Face Masks for Medical Use

Please see Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.  If your product falls under this category, please transmit under intended use code 081.006.

Surgical Masks

Please see Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.  If your product falls under this category, please transmit under intended use code 081.006.

Non-medical Respirators for Healthcare Personnel (e.g. N95, non-NIOSH approved masks, KN95, etc.)

For N95s, please see FDA’s NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.  N95s listed on CDC’s website as NIOSH-approved should be transmitted under intended use code 940.000.  No affirmations of compliance are required to be transmitted at the time of entry, but registration and listing information can be transmitted optionally if available.

For non-NIOSH-approved masks (not from China), please see Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. The FAQs are also helpful.  Non-NIOSH Filtering Facepiece Respirators under EUA that are intended for medical use must be listed in the EUA letter or on Exhibit 1. For respirators authorized under this EUA on Exhibit 1, please transmit under intended use code 940.000.  For non-NIOSH-approved masks that have not received EUA, but appear on the CDC website/listed in the EUA letter, please transmit under intended use code 081.006.  No affirmations of compliance are required to be transmitted at the time of entry, but registration and listing information can be transmitted optionally if available.

For non-NIOSH-approved masks from China, please see Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA letter.  For respirators authorized under this EUA on Appendix A: Authorized Respirators, please transmit under intended use code 940.000.  For non-NIOSH-approved masks that have not received EUA, but appear on the CDC website/listed in the EUA letter, please transmit under intended use code 081.006.  No affirmations of compliance are required to be transmitted at the time of entry, but registration and listing information can be transmitted optionally if available.

Other PPE (gowns, gloves, other apparel, etc.)

On March 30, 2020, the FDA issued Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.  Please read the policy for specific criteria and any temporary waivers from the standard requirements. Products that are listed and meet the criteria in this policy should be transmitted under intended use code 081.006.

COVID Test Kits:

At this time, FDA has issued an Emergency Use Authorization which allows authorized COVID-19 in vitro diagnostic products (IVDs) to be marketed in the U.S. For a list of firms that have received EUA for COVID-19 IVDs, please see: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd. For additional information about these test kits, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.

If the product/firm are listed on the EUA, please transmit under intended use code 940.000, otherwise you should use 081.001.

Hand Sanitizer:

In general, hand sanitizers are regulated by FDA as over the counter (OTC) drug products. Please see this website for FDA’s temporary policies on the preparation of alcohol-based hand sanitizers during the COVID-19 public health emergency: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19. For more information on the drug importation process, including how to register and list, please see: https://www.fda.gov/industry/regulated-products/human-drugs. There are no EUAs or exemptions from the standard import requirements at this time, please transmit under intended use code 130.000.

Thermometers:

At this time, FDA has issued an Enforcement Policy for Clinical Electronic Thermometers.   If your product falls under this category, please transmit under intended use code 081.006.

Infusion Pumps and Accessories: 

At this time, FDA has issued an Enforcement Policy for Infusion Pumps and Accessories for products that are currently cleared for use in the United States.  If your product falls under this category, please transmit under intended use code 081.006.  Manufacturers of devices not already cleared for use in the U.S. may request emergency use authorization as outlined in the enforcement policy.

Ventilators and Accessories and Other Respiratory Devices

At this time, FDA has issued an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices and an Emergency Use Authorization.  If your product falls under the enforcement policy transmit under intended use code 081.006. 

If your product is listed on Appendix B of the EUA transmit under intended use code 940.000.

Sterilizers, Disinfectants, and Air Purifiers

At this time, FDA has issued an Enforcement Policy for Sterilizers, Disinfectants, and Air Purifiers.  If your product falls under this category, please transmit under intended use code 081.006.

 Thank you for your patience as we work to respond to all questions as quickly as possible.

COVID Imports Team

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