COVID-19 Relief Imports

Customs Duties Information

CBP has issued several messages regarding payment of duties/taxes/fees during the COVID-19 pandemic: 

• CSMS #42097586 : Additional Days for Payments due to COVID-19, on 03/20/2020
• CSMS #42161666 : Additional Guidance for Entry Summary Payments Impacted by COVID-19, on 03/26/2020
• CSMS #42179313 : Additional Guidance for Entry Summary Payments Impacted by COVID-19 March 27, 2020, on 03/27/2020
• CSMS #42320854 : Processing International Donations for COVID-19 Response, on 04/09/2020
• CSMS #42355785 : Processing International Donations for COVID-19 Response – email correction, on 04/13/2020
• CSMS #42423171 : COVID-19 – 90 Day Postponement of Payment for the Deposit of Certain Estimated Duties, Taxes, and Fees, on 04/19/2020
• CSMS #42421561 : COVID-19 – Payment Instructions for 90-Day Postponement of Payment for the Deposit of Certain Estimated Duties, Taxes, and Fees, on 04/19/2020
• CSMS #42459926 : CBP.gov Frequently Asked Questions for 90 Day Postponement of Payment for the Deposit of Certain Estimated Duties, Taxes, and Fees, on 04/22/2020

Even though CBP issued CSMS #42097586, allowing the Trade to request postponement for payment of duties/taxes/fees on 3/20/2020, based on information in CSMS #42161666, CBP is no longer accepting duty deferral requests. Any payments due to CBP from 3/20/2020 to 3/26/2020 were due to CBP on 3/27/2020. See the listed messages for additional guidance and instructions.

On 04/09/2020, information regarding international donations was issued in CSMS #42320854. Importation of international donations accepted by the Federal Emergency Management Agency (FEMA) via the International Assistance System (IAS) Concept of Operations (CONOPS) are eligible to be entered without the payment of duty or taxes pursuant to 19 U.S.C. 1322(b) or 19 U.S.C. 1318(b)(2). Shipments meeting these criteria do not require a formal entry and may be released off the manifest.
 
On 04/19/2020, CBP issued CSMS 42423171, notifying the Trade that the Secretary of the Treasury and U.S. Customs and Border Protection (CBP) will be postponing for 90 calendar days the deadline for payment for the deposit of certain estimated duties, taxes, and fees for importers experiencing a significant financial hardship due to the coronavirus disease (COVID-19). This temporary postponement applies to formal entries of merchandise entered, or withdrawn from warehouse, for consumption (including entries for consumption from a Foreign Trade Zone) in March 2020 or April 2020. Please see the message for details. Payment instructions can be found in CSMS 42421561. CBP requests that the Trade not send emails requesting approval for the 90-day postponement as there is no application or approval process. This will allow CBP to focus on reviewing and responding to questions.
 
On 04/22/2020, CBP notified the Trade in CSMS #42459926 that a Frequently Asked Questions section was added to the CBP COVID-19 updates and announcements page. Please check the FAQ often, as it is updated frequently based on questions received from a variety of forums.

You can find CSMS messages and sign up for CSMS alerts via email, SMS or text message at: https://www.cbp.gov/trade/automated/cargo-systems-messaging-service

For all CBP COVID-19 updates and announcements, please visit: https://www.cbp.gov/newsroom/coronavirus

Submitting Letter of Attestation to FEMA via DIS

In order to ensure exports are not unnecessarily delayed Letter of Assestation for FEMA exemption to FEMA should be coded correctly for DIS to ensure they can be provided to FEMA in a timely manner.

The filer should follow these guidelines for submitting the Letter of Attestation to DIS. These guidelines can be found on pg. 80 of Appendix B in the ACE DIS Implementation Guide.

www.cbp.gov/document/guidance/ace-dis-implementation-guide

The filer should email the documents utilizing the subject line format AND email address highlighted below. Very important that utilizing the ITN will make it easier to locate the document in DIS.

APPENDIX B: General Guidelines for Documents Submitted to DIS via Email

These general guidelines are for all document submissions via email except for Export Manifest and Vessel Documents. Vessel document submission may be found in APPENDIX C of this document, and Export Manifest submission guidelines may be found at www.cbp.gov/trade/ace/export-manifest

Anyone submitting the Letter of Attestation to the CBP Document Imaging System (DIS) should following the guidance identified below. CBP can receive .PDFs up to 10 MB in size.

Send email to: docs@cbp.dhs.gov

The email Subject Line: The body of the email should contain the data elements identified below mandatory are required the others are optional. I’ve highlighted those that could be helpful.

TRANSMITTER_NAME = Mandatory (Name of company)
PORT_CD = (4 digit port code) Conditional
POC_INFO = Optional (Name and Phone Number)
COMMENT = Optional (Any clarification/remark)
RETURN_EMAIL_ADDRESS = Optional (if different than sender email address)

Information for Exporters with a Surplus of Medical Supplies and Equipment

Release Date:
May 19, 2021

*This document was updated as of May 19, 2021

FEMA published a Temporary Final Rule (TFR) in the Federal Register on December 31, 2020. It allocates certain scarce critical medical and healthcare resources for domestic use to ensure domestic needs are met during the COVID-19 pandemic, and to ensure supplies of certain materials are not exported abroad inappropriately. The current TFR is in effect until June 30, 2021.

FEMA strives to keep the TFR up to date while reflecting the most current information about critical medical supplies and healthcare resources. The process requires a balance between potential domestic shortages, protection of the national defense interest, promotion of the domestic economy, and an acknowledgment of international and diplomatic considerations.

To adapt to consistently fluid supply chain considerations, FEMA is announcing some changes under the current TFR.

Effective immediately, the following are no longer restricted from export under the TFR:

• Industrial N95 Respirators, including devices that are currently NIOSH approved for use in healthcare settings under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA)
• PPE Surgical Masks, as described by 21 CFR 878.4040, including masks that cover the user’s nose and mouth providing a physical barrier to fluids and particular materials, that meet fluid barrier protection standards pursuant to: ASTM F 1862; and Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards
• Piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes; or
• Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).

The review and restriction from export under the TFR remains unchanged for these items:

• Surgical N95 Respirators, that are single-use, disposable respiratory protective devices used in a healthcare setting that are worn by healthcare personnel during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181.

• PPE Nitrile Gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes.
• Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70

Additional Information

If you are a manufacturer or distributor of one of the remaining covered items under the TFR, and believe you have a surplus you may request an exemption due to a surplus of materials. This is only required for the three covered items remaining , surgical N95 Respirators, PPE Nitrile Gloves, or Level 3 and Level 4 Surgical Gowns and Surgical Isolation Gowns. You will be asked to demonstrate a good-faith and unsuccessful attempt to sell the material to the domestic market.

To request this TFR export process exemption due to a surplus of materials, please submit a Letter of Attestation with the following information to docs@cbp.dhs.gov:

1.  The surplus material you wish to export
2. The commercially reasonable efforts you have made to market and sell the material domestically
3. The difference, to the extent known, between the domestic demand and the domestic production
4. How the proposed export volume will not interfere with continued satisfaction of domestic demand.

DHS-FEMA will review submitted Letters of Attestation and make every effort to provide parties with a Letter of Decision within three business days.

For information on additional exemptions to the allocation order, go to the Notice of Exemptions published in the Federal Register in April 2020.

Export Allocation Rule on Medical Supplies and Equipment for COVID-19 - FEMA

Download Fact Sheet PDF - FEMA

Accessible TXT - FEMA  

COVID-19 Test Kit Importation Requirements

A US company can do the importation process and may be facilitated with the assistance of a broker albeit not required by CBP.  Importation has to meet certain requirements from FDA, USDA, and CDC:

• COVID-19 test kits and associated products are subject to FDA regulations (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency), and admissibility of the test kits are subject to these regulatory requirements.
• Importation of COVID-19 test kits should also comply with APHIS VS import requirements; see guidance: https://www.aphis.usda.gov/animal_health/downloads/import/covid-19-info.pdf
• Information on COVID-19 importation from CDC can be found at  https://www.cdc.gov/cpr/ipp/index.htm, and permit application can be submitted electronically through CDC eIPP system (https://eipp.cdc.gov/).

Test Kits, PPEs & Ventilators
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#sarscov2antibody

Masks
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks

Hand Sanitizers
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

Warning Letters

• FDA Warning Letters https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products
• FTC/FDA Warning Letters https://www.ftc.gov/enforcement/warning-letters?field_tags_tid%5B0%5D=361

Information Update about the Export Allocation Rule on Medical Supplies and Equipment for COVID-19

Release Date:
July 2, 2021

*This document was updated on July 1, 2021

FEMA published a Temporary Final Rule (TFR) in the Federal Register on December 31, 2020. It allocated certain scarce critical medical and healthcare resources for domestic use to ensure domestic needs are met during the COVID-19 pandemic, and to ensure supplies of certain materials are not exported abroad inappropriately. The TFR was in effect until June 30, 2021 and is now expired. There are no current restrictions on these items.

FEMA used the TFR to adapt to consistently fluid supply chain considerations while reflecting the most current information about critical medical supplies and healthcare resources. The process required a balance between potential domestic shortages, protection of the national defense interest, promotion of the domestic economy, and an acknowledgment of international and diplomatic considerations.

The TFR is now expired. All previous export restrictions announced under the TFR are no longer in place.

For continued information about the export process, visit U.S. Customs and Border Protection COVID-19 Info.

For exporter support and investment promotion for industry, visit the U.S. Department of Commerce’s Export Solutions center.

For information about how the U.S. works internationally to promote a strong and dynamic American economy, visit the U.S. Department of State’s Bureau of Economic and Business Affairs.  

Information about Emergency Use Authorizations and other requirements around the COVID-19 response are available at the Department of Health and Human Service’s U.S. Food and Drug Administration.

Visit the FEMA DPA pages to learn more about the Defense Production Act.

This TFR expired as of July 1, 2021.

View the former announcement about the rule, which was dated May 19, 2021

Download Fact Sheet PDF

Export Allocation Rule on Medical Supplies and Equipment for COVID-19

Release Date:
May 19, 2021

*This document was updated as of May 19, 2021

FEMA published a Temporary Final Rule (TFR) in the Federal Register on Dec. 31, 2020  which  allocates certain scarce critical health and  medical resources for domestic use to ensure needs are met for the American public during the COVID-19 pandemic. This is an extension and modification of a previous TFR published on August 10, 2020 and April 10, 2020, which outlined the implementation of the President’s Memorandum, “Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use” issued on April 3, 2020.

This extension allows the rule to remain in effect, with certain modifications, through June 30, 2021. To reflect changing circumstances, modifications were made to the types of exports of certain health and medical resources that FEMA will review and may hold for domestic use. Specifically, FEMA narrowed the scope of the surgical masks subject to the order (see below). Additionally, the agency added certain types of syringes and hypodermic needles to the order, so that these items can be assessed by FEMA prior to export.

The health and medical resources subject to this allocation order include:

• Surgical N95 Respirators
• Nitrile gloves and exam gloves
• Surgical Gowns and Surgical Isolation Gowns

FEMA’s Export Cargo Review Working Group

The Export Cargo Review Working Group regularly reviews shipments, provides advice to FEMA regarding implementation of the allocation order, and continues to evaluate the categories of health and medical resources included in the TFR periodically to consider the proper scope of covered materials. This group includes representatives from Customs and Border Protection (CBP), the Department of State, the Department of Commerce, the Department of Health and Human Services, and the Food and Drug Administration.

Evaluation of Exports Submitted through the Automated Export System

In most situations, planned exports must be declared in advance by exporters, with details about the shipment submitted into CBP’s Automated Export System (AES). CBP will review information submitted into AES to determine if products bound for export are covered under the TFR or if an exemption applies.  If the shipment is covered under the TFR, CBP notifies FEMA and the ECRWG will review and decide on the shipment.  

Under this temporary final rule extension, covered materials may be temporarily detained before leaving the U.S. In making a determination on to allocate the materials for domestic use, FEMA may continue to consult other agencies and will consider the totality of the circumstances, including the following factors:

• The need to ensure that such items are appropriately allocated for domestic use
• Minimization of disruption to the supply chain, both domestically and abroad
• Circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns
• Quantity and quality of the materials
• Humanitarian considerations
• International relations and diplomatic considerations

FEMA will work quickly and make every attempt to review and make determinations to minimize disruptions to the supply chain. If a shipment is detained for review under the TFR, FEMA and CBP will work to provide a response to the owner of the shipment within 72 hours.

If FEMA determines that it is in the national defense interest for a shipment to remain in the U.S to support the COVID-19 pandemic response, the agency may take one of the following three options:

• Purchase part or all of the shipment, using a rated order under Title 1 of the Defense Production Act.
• Return part or all of the shipment for domestic distribution.
• Allow part, or all, of the shipment to be exported.

Exemptions

FEMA has established 11 exemptions that apply to covered items under the TFR. All exemptions listed below apply to the current TFR, issued on December 31, 2020. FEMA will publish any additional exemptions, or modifications, in the Federal Register.

FEMA has grouped these exemptions into two types:

1. Exemptions which do not require a Letter of Attestation. FEMA and CBP will evaluate these shipments and apply appropriate exemptions based on the standard information provided with the shipment.

• Shipments in the following categories may proceed as usual:
• Sealed, sterile medical kits and diagnostic testing kits where only a portion of the kit is made up of one or more covered materials that cannot be easily removed without damaging the kits. 
• Declared diplomatic shipments from foreign embassies and consulates to their home countries. These may be shipped via intermediaries (logistics providers) but are shipped from and consigned to foreign governments. 
• Shipments to overseas U.S. military addresses, foreign service posts (e.g., diplomatic post offices), and embassies.
• Shipments by or on behalf of the U.S. federal government, including its military.
• Shipments to U.S. commonwealths and territories, including Guam, American Samoa, Puerto Rico, U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands (Including minor outlying islands).

1. Exemptions which require a Letter of Attestation. Shipments in the following categories  may be allowed to export, but shippers must provide a Letter of Attestation describing the applicability of an exemption. (See below for information on Letters of Attestation):

• Shipments made by or on behalf of U.S. manufacturers with continuous customer export agreements in other countries since at least January 1, 2020 as long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the U.S. in the preceding 12 months.
• Exports of covered materials by non-profit or non-governmental organizations that are solely for donation to foreign charities or governments for free distribution (not sale) at their destination(s).
• Intracompany transfers of covered materials by U.S. companies from domestic facilities to company-owned or affiliated foreign facilities for internal use. The letter of attestation for this exemption must state the intended use of the covered materials. This exemption does not cover intracompany transfers for the purpose of resale.
• Shipments of covered materials that are exported solely for assembly in medical kits and diagnostic testing kits destined for U.S. sale and delivery.
• In-transit merchandise, or shipments in transit through the U.S. with a foreign shipper and consignee, including shipments temporarily entered into a warehouse or temporarily admitted to a foreign trade zone.
• Shipments for which the final destination is Canada or Mexico.

For more information on these exemptions, see the initial April 10 TFR and the April 21  Notification of Exemptions.

Letters of Attestation

Letters of Attestation are only needed if the shipper plans to export one or more of the covered materials listed in the allocation order, or for the exemptions listed above.

Letters of Attestation must be submitted in conjunction with export paperwork through the Automated Export System (AES) to Customs and Border Protection. The AES allows for the attachment of documents, such as Letters of Attestation, under the tab “Document Imaging System.”

FEMA recommends including the following information in a Letter of Attestation:

• Must be on company letterhead.
• Description of the type and quantity of covered materials that are included in the shipment. (If the shipment does not contain any of the covered materials, there is no need to file the attestation letter, as the shipment falls outside the allocation order)
• A description of which exemption(s) the owner or exporter believes the shipment falls into.
• A brief statement describing why the claimed exemption applies.       
• A brief statement describing the expected end use of the exported materials.
• A statement confirming that the provided information is true and accurate to the best of the exporter’s knowledge, and that the exporter is aware that false information is subject to prosecution under the Defense Production Act, as described in the allocation order

Exporters with a Surplus of Covered Material

If a shipper believes they have a surplus of a covered material and can demonstrate a good-faith and unsuccessful attempt to sell the material domestically, they may be exempt. For more information on this exemption, review the fact sheet regarding surplus of covered material.

Exporters who take Advantage of Exemptions

If CBP believes that an exporter is intentionally modifying  shipments to take advantage of one or more exemptions, CBP may detain the shipment and forward information (including the basis for CBP’s belief of the intentional modification) to FEMA for determination.

CBP, in its discretion, may forward  additional shipments to FEMA for consideration if the agency does not believe a shipment falls clearly into one or more exemptions.

Questions about a specific shipment should be directed to Customs and Border Protection. Questions about the allocation order and Notification of Exemptions in the Federal Register may be directed to FEMA National Business Emergency Operations Center at NBEOC@max.gov.

Additional Resources

Information for Exporters with a Surplus of Medical Supplies and Equipment
Download Fact Sheet PDF
Accessible TXT

New HS Classification Reference for Vaccines and Related Supplies and Equipment (World Trade Organization)

In this new stage of the COVID-19 pandemic, in which vaccines are ready for distribution, the WCO Council has tasked the Secretariat to work with relevant international organizations to develop guidance materials to facilitate the cross-border movement of situationally critical medicines and vaccines, including highlighting existing HS classification for critical medicines, vaccines and associated medical supplies necessary for their manufacture, distribution and use.

The WCO’s Tariff and Trade Affairs Directorate, in close cooperation with the World Health Organization, has prepared a new HS classification reference for vaccines and the medical consumables normally used during the vaccination process, including the equipment used for their storage and transportation. 

The New HS classification reference for vaccines and related supplies and equipment can be found in the WCO COVID-19 vaccines distribution dedicated page: http://www.wcoomd.org/en/topics/facilitation/activities-and-programmes/natural-disaster/covid19-vaccines-distribution.aspx

A MedWatch Safety Alert was added to the FDA Recalls webpage.  

TOPIC:
Hand Sanitizers: FDA Updates on Recalls Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

AUDIENCE:
Consumer, Patient, Health Professional

ISSUE:
FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.

The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.

Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. Do not use any products on this list of hand sanitizers with potential methanol contamination, and continue checking this list often as it is being updated daily. The agency will provide additional information as it becomes available. 

Recent recalls include:

• AAA Cosmética, S.A. de C.V. Issues Voluntary Nationwide Recall of all Lots Within Expiry of bio aaa Advance Hand Sanitizer 480 mL Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
• Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the Potential Presence of Undeclared Methanol (Wood Alcohol) 

BACKGROUND:
Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECOMMENDATION:
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

This list outlines the information on hand sanitizer labels for consumers to use to identify a product that has been tested by FDA and found to contain methanol, that is being recalled by the manufacturer or distributor, or that is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Please note that the CBP COVID19 CCRT and Import Specialists can only provide non-binding opinions related to marking of face masks; binding rulings are issued by Regulations and Rulings.

Depending on who the end user is and the packaging of the product, it is possible that just the container in which the mask is sold, can be marked in accordance with 19USC 1304. Note:

What articles are excepted from marking by 19 U.S.C. 1304?

• An article that is incapable of being marked;
• An article that cannot be marked prior to shipment to the United States without injury to the article;
• An article that cannot be marked prior to shipment to the United States except at an expense economically prohibitive of its importation;
• When the container of an article reasonably indicates the article’s origin; that is, the marked container reaches the ultimate purchaser unopened.
• The article is a crude substance;
• The article is imported for use by the importer and is not intended for sale in its imported or any other form;
• The article is to be processed in the United States by the importer, or for his account, in such a manner that any marking would be permanently concealed, obliterated, or destroyed;
• When the ultimate purchaser, by reason of the article’s character or by reason of the circumstances of its importation, necessarily must know, or in the case of a good from a NAFTA country, reasonably must know, the country of origin of such article even though it is not marked to indicate its origin;
• The article was produced more than 20 years prior to its importation into the United States;

Articles of a class or kind (listed below) imported in substantial quantities for a five year period immediately preceding January 1, 1937, and which were not required to be marked. 

As a binding opinion cannot be given on a product that has not yet made entry into the United States, CBP will make a determination on whether the product meets the marking requirements at time of entry.

Refer to the most current CSMS 42168200 Information for filing Personal Protective Equipment and Medical Devices during COVID 19. Please monitor the Coronavirus FDA page for the latest information: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19.  FDA has also established an N95 Respirators and Surgical Masks (Face Masks) website.

On March 25, 2020, FDA released Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. Please review this guidance document if you are importing these products.  Here are a few of the key points from the guidance document related to face masks:

Other face masks and filtering facepiece respirators (FFRs) that are marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, FDA device marketing authorization is not required, and all the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products. Face Masks and N95 Respirators Not Intended for a Medical Purpose are not required to be transmitted to FDA and can be disclaimed.

See Emergency Use Authorization letter - NIOSH.  NIOSH approved respirators authorized under this EUA are listed in NIOSH CEL for non-powered air purifying respirators with particulate protection and the NIOSH CEL for PAPRs with particulate protection

Under this re-issued letter, manufacturers do not need to submit attestation to FDA in order to request authorization of additional NIOSH-approved respirators and strategic stockpilers do not need to submit request to FDA to request authorization of additional NIOSH-approved respirators.

Note to Importers:

• All descriptive printed material relating to the use of the authorized respirators shall be consistent with applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set forth in this EUA.
• No descriptive printed material relating to the use of the authorized respirators may represent or suggest that the product is safe or effective for the prevention of COVID-19.
• Importers of authorized respirators will notify manufacturers of the terms and conditions of this EUA and ensure that the end user facility (e.g., each hospital, etc.) that receives the authorized respirators also receives the information required under Condition B.
• Importers of authorized respirators will ensure that any records associated with this EUA are maintained until the end of this public health emergency.

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. 

Non-NIOSH Filtering Facepiece Respirators under EUA that are intended for medical use must be listed on Exhibit 1 and have an Emergency Use Authorization to be imported for medical use. See Emergency Use Authorization Letter. 

If you wish to import masks identified in the EUA letter and they are not listed in Exhibit 1, send an email notification to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the following information:

• Specify the manufacturer, model number(s), marketing authorization/certificate from another regulatory authority or conformity assessment body acting on their behalf (including the authorization number (if any)), certificate of conformity (if available), applicable performance standards that their product meets, and any applicable guidance documents.
• An estimate of the number of respirators you are planning to import during the public health emergency,
• A copy of the product labeling. Respirators must comply, at a minimum, with the labeling requirements in conditions A and B under the Conditions of Authorization (Section IV) of this letter.

Please note:  Canada is not listed because it allows self-declaration to NIOSH or equivalent standards.  If importing respirators from Canada, follow the instructions for Filtering Facepiece Respirators (including N95s) under EUA.

For any face mask or filtering facepiece respirator (including N95 respirators) issued an EUA, FDA will include appropriate conditions of authorization in accordance with section 564 of the FD&C Act. Although this is a case-by-case determination, based on current information and experience, we will likely include the following conditions:

• Appropriate conditions designed to ensure that health care professionals administering the device are informed— that FDA has authorized the emergency use of the device; of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; and of the alternatives to the device that are available, and of their benefits and risks.
• Appropriate conditions designed to ensure that individuals to whom the device is administered are informed— that FDA has authorized the emergency use of the device; of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; and of the option to accept or refuse administration of the device, of the consequence, if any, of refusing administration of the device, and of the alternatives to the device that are available and of their benefits and risks.
• Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the device. FDA intends to include conditions that are consistent with those promulgated under 21 CFR Part 803.

For manufacturers of the device, appropriate conditions concerning recordkeeping and reporting, including records access by FDA, with respect to emergency use of the device.

For the most current Information for Filing Personal Protective Equipment and Medical Devices During COVID-19  and Emergency Use Authorizations.

• Due to the large number of inquiries that FDA and CBP have been receiving on importing medical products under one of the guidance documents or an Emergency Use Authorization, we have set up the following email addresses for importers, manufacturers, or brokers to get answers directly from FDA’s Subject Matter Experts:
• Diagnostic tests: COVID19DX@FDA.HHS.GOV
• Ventilators: CDRH-COVID19-Ventilators@fda.hhs.gov
• Surgical masks: CDRH-COVID19-SurgicalMasks@fda.hhs.gov
• Other personal protective equipment (PPE): CDRH-COVID19-PPE@fda.hhs.gov
• Note that surgical masks has its own separate email above
• Hand sanitizers: COVID-19-Hand-Sanitizers@fda.hhs.gov
• General import inquiries: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov
• For more information, please visit the following links to FDA's COVID-19 website
• FDA COVID-19 Homepage
• Q&A for Consumers: Hand Sanitizers and COVID-19
• Animal Health & Safety and the Coronavirus Disease 2019 (COVID-19)

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas

https://content.govdelivery.com/accounts/USDHSCBP/bulletins/2836f88

https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-offices-and-ports-entry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency

https://www.fda.gov/

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits

https://content.govdelivery.com/bulletins/gd/USDHSCBP-2825bb2?wgt_ref=USDHSCBP_WIDGET_2

https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments