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Update: Importation and Distribution of Face Shields and Respirators During COVID-19 Pandemic

This updates our prior Alert regarding the importation and distribution of respirators and other masks to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.  As reported in the news on a daily basis, these products and other personal protective equipment (PPE) are currently in critical short supply due to the high demand by healthcare professionals across the country.

To respond to the current crisis, FDA has recently expanded its Enforcement Discretion Policy for the importation, distribution, and use of certain masks and other PPE intended for medical use.

Specifically, in a Guidance document and EUA issued late last week, FDA describes two approaches that may be used for the U.S. importation/distribution of non-NIOSH approved masks from China when specified criteria are satisfied.[1] This Policy takes effect immediately and is intended to remain in effect only during the COVID-19 public health emergency.

In addition to the updated FDA policy, US Customs and Border Protection (CBP) has also updated some previous guidance for importing PPE and other medical devices during the pandemic. The FDA Policy and CBP updates are summarized below.

Face Shields

FDA has announced that it does not intend to take enforcement action against face shields that do not comply with FDA’s registration and listing, quality system, certain reporting and unique identification requirements (UDI) in the absence of undue risk. As with its other Enforcement Discretion Policies issued to date, FDA provides examples of measures to be taken to mitigate such risk, including recommended labeling.

N95 Respirator Masks

FDA Enforcement Discretion

When FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA does not intend to object to the importation and/or distribution and use of respirators, including KN95 respirators, consistent with CDC policy, notwithstanding the failure to comply with FDA’s premarket notification (“510(k)”), registration and listing, quality system regulation, UDI, and certain reporting requirements. The applicable CDC policy (“Use of respirators approved under standards in other countries that are similar to NIOSH-approved respirators”) can be found here.

Notably, FDA further recommends that importers take appropriate steps to verify the authenticity of these products.

EUA for Non-FDA and Non-NIOSH Approved Masks From China

FDA has also issued a new Emergency Use Authorization (EUA) letter for non-NIOSH-approved respirators manufactured in China, which makes KN95 respirators eligible for authorization if certain criteria are met.

By way of brief background, FDA previously issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under that prior  EUA (which remains in effect), among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea and Mexico who have similar standards to NIOSH. According to FDA, the agency did not list KN95 respirators made per China’s standards in this EUA because of concerns about fraudulent products listed as KN95s.

On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA letter for non-NIOSH-approved N95 respirators manufactured in China. Under this EUA,  KN95 respirators are eligible for authorization if the following conditions are satisfied:

  1. The respirator is manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA; or
  2. The respirator has a regulatory authorization under a jurisdiction other than China that can be authenticated and verified by FDA; or
  3. The respirator demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.

FDA reserves the right to request any additional information that it may need to confirm the respirator’s EUA eligibility.

In addition to one of the above criteria being satisfied, a product to be imported under this EUA must satisfy certain other conditions, including:[2]

A. Manufacturers of authorized respirators must publish on their website an English version of the intended use and other instructions (such as fit testing, etc.) about all authorized models that are imported and authorized under this EUA.

B. In addition to the above electronic labeling condition, manufacturers of authorized respirators must include a letter, in English, that can be distributed to each end-user facility (e.g., each hospital, etc.) that receives the authorized respirator model.

  • This letter must include the authorized respirator’s manufacturer, model, intended use, manufacturer’s webpage (if applicable), etc.

C. Manufacturers of authorized respirators must notify the importer 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 (see above).

D. Manufacturers of authorized respirators must have a process in place for reporting adverse events and send such reports to FDA.

E. All descriptive printed material relating to the use of the authorized respirators in the U.S. must be consistent with applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set forth in the  EUA.

F. No descriptive printed matter relating to the use of the authorized respirators in the U.S.  States may represent or suggest that the product is safe or effective for the prevention of COVID-19.

G. Manufacturers of authorized respirators must maintain records associated with this EUA  until otherwise notified by FDA, and are to be made available to FDA for inspection upon request.

Importers

Similar conditions apply to importers of a device under this EUA, including the all of the same labeling, notification, and general recordkeeping requirements.[3] 
 
CBP/Import Considerations

For products imported from China, accurate tariff classification is vital as it affects whether the products may be eligible for a product exclusion from the Section 301 duties as noted in our international trade alert.

On April 5 CBP sent FDA entry information guidance (CSMS 42272898) for importing COVID–19 supplies. The update explains that for ventilators authorized for emergency use pursuant to an EUA, importers should submit the product code according to the Ventilator EUA, and transmit Intended Use Code (IUC) 940.000.

New enforcement discretion policies have also been issued for Clinical Electronic Thermometers, Gowns, Other Apparel, and Gloves, and Sterilizers, Disinfectant Devices and Air Purifiers related to COVID–19, which are regulated by FDA as a device but not authorized by an EUA. Importers should transmit IUC 081.006. Under both IUCs, affirmations of compliance are optional in ACE.

Additionally, CBP issued an advisory (CSMS 42253103) encouraging importers to use the FDA Import Trade Auxiliary Communication System (ITACS) for current entry status and to receive FDA notices electronically for COVID–19 products. ITACS accounts can be requested via the FDA Unified Registration and Listing System (FURLS).

Additionally, for the most recent mask category granted to use under the EUA, FDA has placed conditions on not only the manufacturers but also importers to ensure that proper labeling/marking and use information is provided to HCPs in the United States.

Conclusion

Issues of requirements for the import/distribution of PPE continue to evolve with the increasingly dire need for increased availability of these products to HCPs in the face of the COVID-19 pandemic. We will continue to monitor and to provide updates on guidance for these products during the pandemic.

[1] In addition, the new Enforcement Policy and EUA also address authorization for the decontamination of face masks and respirators. 

[2] Manufacturers of authorized respirators that are decontaminated by an authorized decontamination system are not responsible for any additional conditions that may apply to the manufacturer and/or operator of the decontamination system unless they are the same manufacturer.

[3] Manufacturers and/or Operators of Authorized Decontamination Systems are also covered by the EUA.  Each manufacturer and/or operator of an authorized decontamination system for decontamination of authorized respirators must comply with the Conditions of Authorization and authorized labeling as set forth in the Letter of Authorization for the authorized decontamination system. 

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