Introduction

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:

  • equipment intended for medical use by healthcare professionals in hospitals and medical facilities; and
  • equipment intended for general purpose or industrial use (ie, not intended to be distributed or marketed for medical use).

Notably, these policies are changing rapidly. It is recommended that those looking to source overseas monitor these changes.

FDA-regulated products for medical use

Products needed 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:

  • eye protection;
  • isolation gowns;
  • surgical masks; and
  • N95 respirators – specialised masks used to protect the wearer from airborne particles and from liquid contaminating the face.

Surgical masks and N95 respirators are medical equipment regulated by:

  • the FDA;
  • the Centres for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH); and
  • the Occupational Safety and Health Administration.

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:

  • NIOSH-approved disposable respirators classified as non-powered air-purifying particulate FFRs; and
  • respirators that were NIOSH approved but which have exceeded the manufacturer's recommended shelf life.

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:

  • a commercial description of the goods;
  • the manufacturer (ie, any person which manufactures, prepares, propagates, compounds, assembles or processes a device by chemical, physical, biological or other procedure);
  • the shipper (ie, the actual shipper of the product. This can typically be determined from the freight bill or bill of lading. The FDA shipper may be the same entity as the invoicing party);
  • the FDA 'importer' (ie, the company or individual in the United States that is an owner, consignee or recipient, even if not the initial owner, consignee or recipient, of the foreign establishment's device that is imported into the United States);
  • the device initial importer;
  • the FDA country of origin;
  • the FDA product code, which may be one of the following:
    • surgical masks (FXX);
    • surgical masks with an antimicrobial or antiviral agent (OUK);
    • paediatric or child facemasks (OXZ);
    • surgical gowns (FYA);
    • isolation gowns and surgical apparel accessories (FYC, LYU or OEA); or
    • surgical suits (FXO);
  • the tariff code or tariff classification – Harmonised Tariff Schedule (HTS) of the United States. For example, surgical masks and N95 respirators fall under Tariff Classification 6307.90.9889. Goods from China have special tariffs on them called 'Section 301 tariffs'. Although Section 301 tariffs imposed on Chinese goods apply to this provision, as of 17 March 2020, the US Trade Representative has excluded both "[f]ace masks, single-use, of textile fabrics", including surgical masks, and "[s]ingle-use medical masks of textile material", including N95 respirators. Importers should use Tariff Code 9903.88.42 to claim this exclusion;
  • the quantity of the goods;
  • the value of the goods;
  • the consignee;
  • the FDA facility registration number or Data Universal Numbering System number; and
  • affirmation of compliance codes and qualifiers (providing complete affirmation of compliance information for devices expedites the FDA release process). Each entry line should contain an affirmation of compliance code for:
    • the device's foreign manufacturer or device foreign exporter;
    • the device listing;
    • the device's initial importer; and
    • a pre-market application (which can also be a humanitarian device exemption or a product development protocol number), a pre-market notification number or an investigational device exemption.

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:

  • diagnostic tests (QPK, OTG, QKO and QJR); and
  • masks and respirators (NZJ).(4)

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.

Non-FDA regulated products for general purpose or industrial use

The CBP's 23 March 2020 CSMS #42124872 also provided guidance for importing PPE for general purpose or industrial use, including:

  • non-FDA-regulated general-purpose PPE (eg, masks, respirators and gloves); and
  • PPE for general purpose or industrial use (ie, products that are not intended for use to prevent disease or illness) that is not FDA regulated.

For these types of product, entry information should not be transmitted to the FDA. At the time of entry for these products, importers should:

  • transmit entry information to the CBP using an appropriate HTS code with no FD flag or an appropriate HTS code with an FD1 flag; and
  • do a 'disclaim' for the FDA.

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.

Comment

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.

Endnotes

(1) Requests should be emailed to the CDC at '[email protected]'.

(2) See the FDA's 2 March 2020 EUA letter, p 6.

(3) The FDA's general EUA guidance can be found here.

(4) Questions regarding appropriate product coding can be submitted to the FDA at '[email protected]'. Requests for an EUA can be submitted to the FDA at '[email protected]' for diagnostic devices and '[email protected]' for non-diagnostic devices.