The Importation of Personal Protective Equipment for Treatment of COVID-19

Masks, ventilators, and gowns are difficult to find in the United States and hospitals are putting out desperate pleas for supplies.

People are looking overseas to source these items. We provide some basic guidance for importing these items to satisfy US import requirements and to facilitate quick processing through clearance. Many of these items are regulated by the Food and Drug Administration as medical devices and are also subject to US Customs and Border Protection regulations. We break this 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 (i.e., not intended to be distributed or marketed for medical use).

We also note that these policies are changing rapidly, even on a daily basis. We recommend 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 health care providers safe from the disease. Necessary PPE for COVID-19 includes eye protection, isolation gowns, surgical masks, and N95 respirators — specialized 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, Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health, and Occupational Safety and Health Administration.

FDA Regulatory Requirements

In addition to the US Customs requirements, as well as the export requirements of the applicable country, the importation of PPE for healthcare use must comply with all FDA requirements. But what are those requirements? The answer to this question can be expected to evolve just as the US response to the COVID-19 pandemic continues to evolve rapidly. The short answer, however, is that the applicable FDA requirements depend on the specific type of PPE.

At the current time, the importation of nearly all types of PPE hasn’t changed. This means that they must comply with FDA’s premarket clearance and all other regulatory requirements. That said, in an effort to address the critical shortage of protective masks for healthcare workers, FDA has made a recent exception for certain NIOSH-approved masks. This exception, as well as other PPE not falling within that category, is summarized below.

PPEs Other Than Certain NIOSH-Approved Masks

As a general matter, because healthcare PPE is intended for use in the diagnosis, treatment, mitigation, prevention or cure of disease, it is subject to regulation by FDA as a medical device under the U.S. 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 authorization (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 (e.g., a surgical mask with the FDA-assigned product code MSH).

For non-510(k) exempt devices, a specific manufacturer’s gowns, and surgical masks can be identified by searching FDA’s 510(k) database using the 3-letter product codes that FDA has assigned to those products: for gowns (FYA, FYB, FYC); and for surgical masks (FXX, OUK, OXZ). Similarly, 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. For product codes and other regulatory information concerning medical gloves, see FDA’s “FAQs on Medical Gloves” (March 2020).

In addition, all imported PPE (including 510(k) exempt devices) must comply with other FDA requirements such as FDA’s current good manufacturing practices, including the quality system requirements under 21 CFR Part 820, concerning the design, manufacture, labeling, storage, and distribution of the product, as well as FDA’s establishment registration and listing requirements. Notably, these other FDA requirements apply to a medical device, including PPEs, regardless of whether it is subject to a 510(k) or, instead, is one of the few that might be 510(k) exempt.

Certain NIOSH –Certified Personal Respiratory Protective Masks

As an exception to FDA’s 510(k) requirements, FDA has the statutory authority to issue Emergency Use Authorizations (“EUAs”) for the use of a medical device (or a drug) to address a public health emergency. On March 2, 2020, the FDA did just this and issued an EUA solely for emergency use of certain NIOSH-approved “filtering face-piece respirators” (“FFRs” or “respirators”) 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 (1) certain NIOSH-approved disposable respirators classified as non-powered air-purifying particulate FFRs; and (2) certain respirators that were NIOSH-approved but which have exceeded the manufacturer’s recommended shelf life. Importantly, this EUA applies only to those respirators specifically authorized by FDA. The current list of the respirators eligible for authorization under the EUA can be found at Appendix A, and the current list of authorized respirators can be found at Appendix B.

Respirators can be added to the FDA’s list of authorized respirators upon submission of a request from the manufacturer, CDC, or strategic stockpile pursuant to the Conditions of Authorization specified by FDA in its March 2nd letter. See FDA’s March 2, 2020, EUA letter, pp. 5-6. Manufacturers may request such authorization via submission of an attestation to FDA (with a copy to CDC (CVSDBadmin@cdc.gov)) specifying the NIOSH-approval number, model number, and place of manufacturer. Such requests are to be made in consultation with, and the concurrence of, FDA’s Center for Devices and Radiological Health, Division of Infection Control.

As part of this EUA, FDA has waived current good manufacturing practice requirements, including the quality system requirements under 21 C.F.R. Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized respirators subject to the EUA. Notably, though, such waiver does not extend to NIOSH requirements, including requirements for NIOSH-approved labeling and/or applicable CDC recommendations. FDA’s EUA authorization letter requires the authorized respirators to be consistent with the terms set forth in the EUA “and the applicable requirements set forth in the FDCA and FDA regulations.” FDA further notes that manufacturers are required to maintain any records associated with the EUA until otherwise notified by FDA and are to be made available to FDA for inspection upon request. See March 2nd EUA letter at 6.

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 U.S.C. 247d-6d, as recently amended by the Families First Coronavirus Response Act (H.R. 6201). The EUA remains in effect until termination of the declaration that circumstances exist justifying the authorization 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, we highly recommend close coordination between your Customs broker, US Customs, and FDA since this EUA has only recently been put into effect.

Once FDA terminates the EUA, the FFRs will no longer be deemed medical devices (and no longer subject to FDA’s requirements/jurisdiction) provided that they are not distributed, marketed, or labeled with an intended medical use.

FDA’s EUA Authority More Generally

Finally, it should be noted that the FDA’s authority to issue EUAs extends broadly to other devices and drugs. The EUA discussed in this Alert applies only to certain respirators, but additional EUAs can be sought. Therefore, should you wish to market in, or import into, the US another device or drug that has not been yet approved by FDA, you may wish to consider seeking an EUA as a possible option for doing so.

FDA’s general EUA guidance can be found here.

Basic FDA Import Requirements

Medical devices imported into the United States must meet the requirements of 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 premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.

Devices must meet FDA regulations prior to the importation of medical devices into the United States. FDA does not recognize regulatory approvals from foreign countries/areas.

All foreign firms are required to both register their establishments, identify a US Agent, and individually list their devices before they may import them into the United States.

The data elements below are important information for you to provide to the folks who are helping you to import the goods:

• Commercial Description
• Manufacturer - Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.
• Shipper is the actual shipper of the product. This can typically be determined from the freight bill or bill of lading, etc. The FDA Shipper may be the same entity as the invoicing party.
• FDA Importer (FD1) Importer means a 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.
• Device Initial Importer (DII); and
• FDA Country of Origin
• FDA Product Code (Product codes in parentheses); many PPE product codes are:
  • Surgical masks (FXX)
  • Surgical masks with antimicrobial/antiviral agent (OUK)
  • Pediatric/child facemasks (OXZ)
  • Surgical gowns (FYA)
  • Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
  • Surgical suits (FXO)
• Tariff Code/Tariff Classification – Harmonized Tariff Schedule of the United States (HTSUS). 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 March 17, 2020, the U.S. Trade Representative has excluded both “Face masks, single-use, of textile fabrics,” including surgical masks, and “Single-use medical masks of textile material,” including N95 respirators.
  • Importers should use the tariff code 9903.88.42 to claim this exclusion.
• Quantity
• Value
• Consignee
• FDA Facility Registration number or DUNS –
• Affirmation of Compliance (AofC) codes and qualifiers; providing complete AofC information for devices expedites the FDA release process.
  • Each entry line should contain an AofC code for:
  • Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
  • Device Listing (LST)
  • Device Initial Importer (DII)
  • Premarket Application (PMA) (Can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number) OR a Premarket Notification Number (PMN) OR an Investigational Device Exemption (IDE)

In certain instances, importers may be subject to reporting requirements as an importer of medical devices.

On March 23, 2020, 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 are imported under an EUA:

• Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)
  • When importing such products, entry information should be submitted to 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.
  • Below is a list of products and the appropriate product codes that are currently authorized by an EUA:
    • Diagnostic tests: QPK, OTG, QKO, QJR 
    • Masks/Respirators: NZJ

Questions regarding appropriate product coding can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.

Requests for Emergency Use Authorization can be submitted to FDA at: CDRH-EUA-Templates@fda.hhs.gov (for diagnostic devices) and CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov(for non-diagnostic devices)

• Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

When importing such devices, entry information should be submitted to 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.

Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which contain product codes within the scope of each guidance:

• Non-Invasive Remote Monitoring Devices

• Ventilators and Accessories and Other Respiratory Devices

A full list of all guidance documents related to COVID-19 is also available on FDA’s website.

Non-FDA Regulated Products for General Purpose or Industrial Use

CBP’s March 23, 2020 Customs Service Message System (CSMS) #42124872 also provided guidance re for importing PPE for general purpose or industrial use:

• Non-FDA-regulated general-purpose personal protective equipment (masks, respirators, gloves, etc.):
  • Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA.
  • For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for 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.

Conclusion

The current import-export and FDA regulatory regimes are complex and evolving rapidly almost on a daily basis given the scope of the COVID-19 pandemic. Therefore we highly recommend that you consult with your Arent Fox Trade or Food and Drug counsel.