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03 April 2020
Due to the COVID-19 pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.
Masks, ventilators and gowns are difficult to find in the United States and hospitals are putting out desperate pleas for supplies.
With people looking overseas to source these items, this article provides some basic guidance for importing them in a way which satisfies US import requirements and facilitates quick processing through clearance. Many of these items are regulated by the Food and Drug Administration (FDA) as medical devices and are also subject to US Customs and Border Protection (CBP) regulations. For the purposes of this article, the items are divided into two categories:
Notably, these policies are changing rapidly. It is recommended that those looking to source overseas monitor these changes.
In the face of the pandemic, hospitals and medical facilities are facing a shortage of personal protective equipment (PPE) to keep doctors, nurses and other healthcare providers safe from the disease. Necessary PPE for COVID-19 includes:
Surgical masks and N95 respirators are medical equipment regulated by:
FDA regulatory requirements
In addition to the CBP requirements and the applicable country's export requirements, the importation of PPE for healthcare use must comply with all FDA requirements. Those requirements are expected to evolve alongside the US response to the COVID-19 pandemic; however, in short, the applicable FDA requirements depend on the specific type of PPE.
The importation of nearly all types of PPE has not changed. This means that the equipment must comply with the FDA's pre-market clearance and all other regulatory requirements. Yet, to try and address the critical shortage of protective masks for healthcare workers, the FDA has made a recent exception for certain NIOSH-approved masks. This exception and other types of PPE not falling within that category are discussed below.
PPE other than certain NIOSH-approved masks
In general, because healthcare PPE is intended for use in the diagnosis, treatment, mitigation, prevention or cure of disease, it is subject to FDA regulation as a medical device under the US Food, Drug and Cosmetic Act. Therefore, most healthcare PPE – including gowns, goggles, gloves and, until recently, all protective masks – must have either an FDA marketing authorisation (which in this case is an FDA-cleared, pre-market or 510(k) notification) or be classified as a 510(k)-exempt Class 1 device (eg, a surgical mask with the FDA-assigned product code MSH).
Non-510(k)-exempt devices, specific manufacturer's gowns and surgical masks can be identified by searching the FDA's 510(k) database using the three letter product codes that the FDA has assigned to those products (ie, FYA, FYB or FYC for gowns and FXX, OUK or OXZ for surgical masks). For a type of PPE other than a surgical mask or gown, this database can be searched by the product code assigned for that type of device to determine whether the specific manufacturer's product sought to be imported has received 510(k) clearance. Product codes and other regulatory information concerning medical gloves are set out in the FDA's FAQs on medical gloves.
In addition, all imported PPE (including 510(k)-exempt devices) must comply with other FDA requirements, such as good manufacturing practices – which include the quality system requirements under 21 CFR Part 820 concerning the design, manufacture, labelling, storage and distribution of the product – as well as the FDA's establishment registration and listing requirements.
Notably, these other FDA requirements apply to medical devices, including PPE, regardless of whether they are subject to a 510(k) or are one of the few 510(k)-exempt devices.
Certain NIOSH–certified personal respiratory protective masks
As an exception to the FDA's 510(k) requirements, it has the statutory authority to issue emergency use authorisations (EUAs) for the use of a medical device or drug to address a public health emergency. On 2 March 2020 the FDA issued an EUA solely for emergency use of certain NIOSH-approved filtering face-piece respirators (FFRs) for use in healthcare settings by healthcare professionals to prevent wearer exposure to pathogenic biological airborne particulates during shortages resulting from the COVID-19 outbreak.
This EUA applies to certain:
Importantly, this EUA applies only to respirators specifically authorised by the FDA. The list of respirators eligible for authorisation under the EUA and the list of respirators currently authorised can be found on the FDA's website.
Respirators can be added to the FDA's list of authorised respirators upon submission of a request from the manufacturer, the CDC or the Strategic National Stockpile pursuant to the conditions of authorisation specified by the FDA in its 2 March 2020 EUA letter (pp 5-6). Manufacturers may request such authorisation via the submission of an attestation to the FDA (with a copy to the CDC)(1) specifying the NIOSH-approval number, model number and place of manufacture. Such requests should be made in consultation with, and the concurrence of, the FDA's Centre for Devices and Radiological Health, Division of Infection Control.
As part of this EUA, the FDA has waived the good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacturing, packaging, labelling, storage and distribution of the authorised respirators subject to the EUA.
Notably, the waiver does not extend to NIOSH requirements, including requirements for NIOSH-approved labelling and applicable CDC recommendations. The FDA's EUA authorisation letter requires the authorised respirators to be consistent with the terms set out in the EUA "and the applicable requirements set forth in the FDCA and FDA regulations". The FDA further notes that manufacturers must maintain any records associated with the EUA until otherwise notified by the FDA and should be made available to the FDA for inspection upon request.(2)
While the EUA remains in effect, FFRs included within its scope are subject to the liability protections provided under the Public Readiness and Emergency Preparedness Act (42 USC 247d-6d), as recently amended by the Families First Coronavirus Response Act (HR 6201). The EUA remains in effect until termination of the declaration that circumstances exist justifying the authorisation of the emergency use of the respirators, or until the EUA is revoked, under Section 564 of the act.
Although FFRs satisfying all of the EUA criteria should be permissible for importation, close coordination between customs brokers, the CBP and the FDA is highly recommended since this EUA was only recently put into effect.
Once the FDA terminates the EUA, the FFRs will no longer be deemed medical devices (and will no longer be subject to the FDA's requirements or jurisdiction), provided that they are not distributed, marketed or labelled with an intended medical use.
FDA's EUA authority
The FDA's authority to issue EUAs extends broadly to other devices and drugs. The EUA discussed in this article applies only to certain respirators, but additional EUAs can be sought. Therefore, when marketing in or importing into the United States another device or drug that has not been yet approved by the FDA, it is advisable to consider seeking an EUA as a possible option for doing so.(3)
Basic FDA import requirements
Medical devices imported into the United States must meet the requirements of the CBP and the FDA. Each type of device is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
The class to which a device is assigned determines, among other things, the type of pre-marketing submission or application required for FDA clearance to market. If a device is classified as Class I or II and is not exempt, a 510(k) will be required for marketing.
Devices must meet FDA regulations prior to the importation of medical devices into the United States. The FDA does not recognise regulatory approvals from foreign countries or areas.
All foreign firms must register their establishments, identify a US agent and individually list their devices before they may import them into the United States.
Below is important information to have on hand when importing goods:
In certain instances, importers may be subject to reporting requirements as importers of medical devices.
On 23 March 2020 the CBP issued Customs Service Message System (CSMS) #42124872 - Information for Filing Personal Protective Equipment and Medical Devices During COVID-19.
The CBP provides the following information for medical PPE that is imported under an EUA.
Products authorised for emergency use pursuant to an EUA
When importing such products, entry information should be submitted to the FDA. However, reduced FDA information is required for review.
At the time of entry, importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use and an appropriate FDA product code.
The products and the appropriate product codes that are currently authorised by an EUA are:
Products which are regulated by the FDA as a device and not authorised by an EUA, but where an enforcement discretion policy has been published in guidance
When importing such devices, entry information should be submitted to the FDA.
At the time of entry, importers should transmit an Intended Use Code of 081.006: Enforcement discretion per final guidance and an appropriate FDA product code.
The following guidance documents have been issued for specific products relating to COVID-19 and contain product codes within their scope:
A full list of all guidance documents relating to COVID-19 is available on the FDA's website.
The CBP's 23 March 2020 CSMS #42124872 also provided guidance for importing PPE for general purpose or industrial use, including:
For these types of product, entry information should not be transmitted to the FDA. At the time of entry for these products, importers should:
PPE imports conforming to a general purpose or industrial use only, absent compliance with applicable FDA requirements, cannot be imported if they are intended to be distributed or marketed for medical use.
The import-export and FDA regulatory regimes are complex and evolving almost daily given the scope of the COVID-19 pandemic. Therefore, it is highly recommended that importers consult counsel on these matters.
For further information on this topic please contact David Salkeld, Deborah M Shelton, Robert E Shervette or Russell A Semmel at Arent Fox LLP by telephone (+1 202 857 6000) or email (email@example.com, firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Arent Fox LLP website can be accessed at www.arentfox.com.
(1) Requests should be emailed to the CDC at 'CVSDBadmin@cdc.gov'.
(4) Questions regarding appropriate product coding can be submitted to the FDA at 'COVID19FDAIMPORTINQUIRIES@fda.hhs.gov'. Requests for an EUA can be submitted to the FDA at 'CDRH-EUA-Templates@fda.hhs.gov' for diagnostic devices and 'CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov' for non-diagnostic devices.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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