This article concerns the import and distribution of respirators and other masks to be used to meet the significant US healthcare 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 among healthcare professionals across the United States (for further details please see "Importation of personal protective equipment for COVID-19 treatment").
In response to the current crisis, the US Food and Drug Administration (FDA) recently expanded its Enforcement Discretion Policy for the import, distribution and use of certain masks and other PPE intended for medical use.
Specifically, in a guidance document and emergency use authorisation (EUA) issued in the week commencing 30 March 2020, the FDA describes two approaches that may be used for the US import and distribution of non-National Institute for Occupational Safety and Health (NIOSH) approved masks from China when specified criteria are satisfied.(1) This policy took 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 updated some previous guidance for importing PPE and other medical devices during the pandemic. The FDA policy and CBP updates are summarised below.
The FDA has announced that it does not intend to take enforcement action against face shields that do not comply with its 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, the FDA provides examples of measures to be taken to mitigate risks, including recommended labelling.
FDA enforcement discretion
When FDA-cleared or NIOSH-approved N95 respirators are unavailable, the FDA does not intend to object to the import or distribution and use of respirators, including KN95 respirators, consistent with Centres for Disease Control and Prevention (CDC) policy, notwithstanding the failure to comply with the FDA's pre-market 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, the 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
The FDA has also issued a new EUA letter for non-NIOSH-approved respirators manufactured in China, which makes KN95 respirators eligible for authorisation if certain criteria are met.
By way of brief background, the FDA previously issued an EUA for importing non-NIOSH-approved N95 respirators. Under that prior EUA (which remains in effect), among other criteria, the FDA accepts marketing authorisation from Australia, Brazil, Europe, Japan, Korea and Mexico which have similar standards to NIOSH. According to the FDA, it did not list KN95 respirators made per China's standards in this EUA because of concerns about fraudulent products listed as KN95s.
On 3 April 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 authorisation if the respirator:
- is manufactured by an entity that holds one or more NIOSH approvals for other filtering facepiece respirator models produced in accordance with the applicable standards of authorisation in other countries that can be verified by the FDA; and
- has a regulatory authorisation under a jurisdiction other than China that can be authenticated and verified by the FDA;
- demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognised independent test laboratory that can be verified by the FDA.
The FDA reserves the right to request any additional information that it may need to confirm a 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 as follows:
- Manufacturers of authorised respirators must publish on their website an English version of the intended use and other instructions (eg, fit testing) for all authorised models that are imported and authorised under this EUA.
- In addition to the above electronic labelling condition, manufacturers of authorised respirators must include a letter, in English, that can be distributed to each end-user facility (eg, hospital) that receives the authorised respirator model. This letter must include such information as the authorised respirator's manufacturer, model, intended use and manufacturer's webpage (if applicable).
- Manufacturers of authorised respirators must notify the importer of the terms and conditions of this EUA and ensure that each end-user facility (eg, hospital) that receives the authorised respirators also receives the information required under the second bullet above.
- Manufacturers of authorised respirators must have a process in place for reporting adverse events and send such reports to the FDA.
- All descriptive printed material relating to the use of authorised respirators in the United States must be consistent with the applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set out in the EUA.
- No descriptive printed matter relating to the use of authorised respirators in the United States may represent or suggest that the product is safe or effective for the prevention of COVID-19.
- Manufacturers of authorised respirators must maintain records associated with this EUA until otherwise notified by the FDA and make these available to the FDA for inspection on request.(2)
Similar conditions apply to importers of a device under this EUA, including all of the same labelling, notification and general recordkeeping requirements.(3) CBP and 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 (for further details please see "COVID-19 and Section 301 tariffs: USTR excludes some products and solicits requests to exclude more").
On 5 April 2020 CBP sent the FDA entry information guidance (CSMS 42272898) for importing COVID-19 supplies. The update explains that for ventilators authorised 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 sterilisers, disinfectant devices and air purifiers relating to COVID-19, which are regulated by the FDA as devices but are not authorised by an EUA. Importers should transmit IUC 081.006. Under both IUCs, affirmations of compliance are optional in the Automation Control Environment.
Additionally, CBP issued an advisory (CSMS 42253103) encouraging importers to use the FDA Import Trade Auxiliary Communication System (ITACS) for current entry status and receive FDA notices electronically for COVID-19 products. ITACS accounts can be requested via the FDA's Unified Registration and Listing System.
In addition, for the most recent mask category granted to use under the EUA, the FDA has placed conditions on not only the manufacturers, but also importers to ensure that proper labelling, marking and use information is provided to healthcare professionals in the United States.
Issues of requirements for the import or distribution of PPE continue to evolve with healthcare professionals' increasingly dire need for these products in the face of the COVID-19 pandemic.
Endnotes
(1) The new enforcement policy and EUA also address authorisation for the decontamination of face masks and respirators.
(2) Manufacturers of authorised respirators that are decontaminated by an authorised decontamination system are not responsible for any additional conditions that may apply to the manufacturer or operator of the decontamination system unless they are the same manufacturer.
(3) Manufacturers and operators of authorised decontamination systems are also covered by the EUA. Each manufacturer and operator of an authorised decontamination system for the decontamination of authorised respirators must comply with the conditions of authorisation and authorised labelling as set out in the letter of authorisation for the authorised decontamination system.
