Importing critical healthcare supplies during the COVID-19 pandemic: Recent US developmentsCOVID-19 Alert | International Trade Alert
Even in the best of times, importing medical devices and healthcare supplies into the US can present challenges, given the complex legal, regulatory and enforcement landscape. Now, the country must look beyond its borders to meet the urgent demand for critical medical products to address the coronavirus disease 2019 (COVID-19) pandemic. Practical guidance is critical to help importers of these products efficiently navigate legal and regulatory hurdles so that admissible products with the potential to safeguard patients’ health and well-being may be granted entry into US markets as expeditiously as possible.
Below we provide an update on new administrative guidance from US Customs and Border Protection (CBP) and the US Food and Drug Administration (FDA) intended to facilitate entry of critically needed medical products into the US while continuing to provide US patients and consumers with important protections from fraudulent or illegal products.
Importing medical products – an overview
All products offered for entry into the US must be declared to CBP, and CBP refers all FDA-regulated products to FDA for review.
Licensed customs brokers can help facilitate the import process into the US by filing the necessary customs entry information with CBP on behalf of importing companies (i.e., the “importers of record” on a transaction), advising those companies on procedural issues, and by ensuring payment of necessary duties and fees to CBP. Importers of record, however, remain responsible for exercising reasonable care in the import and entry process, including ensuring that the imported item is allowed to be imported (ie, is “admissible”).
This requires, at the time of importation, compliance with applicable requirements and observance of relevant restrictions imposed by other agencies, including, in the case of medical products, FDA.
The applicable FDA regulations and requirements vary from product to product, and also depend on a product’s stage of development (i.e., whether it is for research and development use only, clinical investigation, or intended for commercial distribution and use). Under normal circumstances, FDA-regulated products intended for commercial distribution and use must, among other things, be FDA-cleared or -approved (unless a product type is exempt from the need for marketing authorization), manufactured pursuant to US good manufacturing practices (GMPs) in an FDA-registered establishment, and labeled consistently with FDA law. Similarly, under normal circumstances FDA also imposes a variety of regulatory requirements on the initial importer of a medical device. For any import of medical devices into the US, FDA requires the importer to provide certain key information about the import to CBP and FDA so that the agencies can work in coordination to assess the compliance status of the shipment and determine whether it is allowed to enter the US.
It is not uncommon for confusion or disputes at the border to result in imports being detained. At a minimum, detention delays the release of goods for distribution and use. If compliance issues with respect to a good cannot be successfully resolved, the good ultimately may be refused entry, and must then either be destroyed or exported out from the US. CBP has no discretion to allow admission of any product that has been refused entry by FDA.
Recent COVID-19-specific developments
In response to the COVID-19 outbreak, FDA has increased its regulatory flexibility with respect to certain devices important to addressing the COVID-19 pandemic, including SARS-CoV-2 testing kits, personal protective equipment (such as masks and surgical gowns), and ventilators. FDA has also increased regulatory flexibility to allow for the distribution and use in healthcare settings of products that are normally intended for use in non-medical industrial settings, such as filtering facepiece respirators and powered air purifying respirators regulated by National Institute for Occupational Safety and Health (NIOSH).
In recognition of the critical role importation will play in meeting the US demand for these products, FDA announced that it was easing certain FDA-imposed import screening requirements for some categories of COVID-19-specific products. This guidance was communicated to stakeholders via CBP’s Cargo Systems Messaging Service (CSMS) and updated shortly thereafter. The guidance set forth in the CSMS (summarized below) clarifies which types of products are currently exempted from certain FDA requirements and can be imported without engaging with FDA. The CSMS also outlines the applicable product codes and processes that should be used for certain key COVID-related products.
This new guidance from FDA and CBP is intended to help stakeholders navigate this unprecedented environment and seeks to remove some of the potential obstacles and delays at the border for products that FDA is permitting to be distributed during the pandemic.
Since the guidance was issued, FDA has reiterated its commitment to facilitating the import of necessary medical products, including personal protective equipment such as surgical masks, gowns and gloves. Indeed, at a recent Virtual Town Hall, FDA representatives repeatedly urged manufacturers and importers of COVID-19-related medical products to contact FDA representatives via email as soon as they have identified a product intended for importation, so that FDA can work to actively assist importers in navigating all import-related issues and ensure successful importation.
The recent CSMS message (CSMS #42168200, updating CSMS# 42124872, “Information for Filing PersonalProtective Equipment and Medical Devices DuringCOVID-19”) divides COVID-related medical product imports into three categories, which track FDA’s evolving, flexible approach to regulation and enforcement of certain COVID-related devices in the context of the current pandemic:
CSMS Category 1: Personal Protective Equipment for Non-Healthcare Use.Personal protective equipment (PPE) intended 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 this category of products, the entry information should be transmitted directly to CBP and not to FDA.
CSMS Category 2: Products Authorized for Emergency Use Pursuant to an Emergency Use Authorization (EUA). EUAs are issued by FDA in response to an emergency declaration by HHS. Products operating under an EUA would ordinarily require FDA approval and/or clearance but have been specifically exempted from those requirements by FDA in connection with the response to a particular public health emergency, subject to certain conditions imposed. Notably, EUAs are issued for individual products or, in some cases, for a class of products that meets certain requirements (and here, an applicant must seek to have their relevant product added to FDA’s list under the EUA). In either case, the specific product must be documented in an EUA in order to qualify.
- As set forth in the CSMS, information regarding imported products that are authorized for emergency use under an EUA should be transmitted directly to FDA, but the amount of information that will be reviewed by FDA is reduced.
- To date, FDA has issued EUAs in connection with several areas related to COVID-19:
- individual diagnostic tests (a list of the tests that have received EUA authorization is available here);
- ventilators (and certain devices modified for use as ventilators), along with ventilator tubing and accessories (a list of authorized products is available here), and
- certain types of PPE used in healthcare settings.
- Importantly, whether any given PPE falls into CSMS Category 1 (i.e., general use PPE) or this Category 2 depends not only upon the use for which it was initially manufactured but also upon its intended use in the United States. Many respirators/masks originally developed for use in industrial settings have been granted an EUA for use in healthcare settings in connection with the COVID-19 response and hence fall into this CSMS Category 2. Therefore, entry information must be transmitted to FDA if the product is being imported for healthcare use. The CSMS message clarifies this situation by providing the sources for logistical references (e.g., “intended use” and “product codes”) needed to make the distinction between when the import information can be submitted directly to CBP or must initially go to FDA.
- Importers of products under an EUA should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device for EUA-authorized products, along with the appropriate FDA product codes. For EUA-authorized diagnostic tests, the codes are 83QKP, 83QKO and 83QJR. For masks/respirators, the code is 80NZJ.
- New 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).
CSMS Category 3:Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.
- FDA has issued several guidance documents indicating its intent to exercise enforcement discretion with respect to certain COVID-19-related FDA-regulated medical products, meaning that FDA will permit the distribution and use of those products − provided they meet certain criteria − even if they have not been cleared or approved by FDA. For all products that fall within the scope of one of FDA’s enforcement discretion policies, entry should be submitted to FDA, and importers should transmit an Intended Use Code of 081.006: Enforcement discretion per final guidance and an appropriate FDA product code.
- A list of all COVID-19-related guidance documents, including all enforcement discretion policies issued to date, is available here. At present, FDA has issued enforcement discretion policies for certain face masks and respirators; ventilators and accessories and other respiratory devices; validated SARS-CoV-2 diagnostic and serology tests; and non-invasive remote monitoring devices (eg, wearable, hand-held, and stationary in-home monitoring and digital interfaces). Each of these policies contains important limitations and requirements that must be met to qualify for exemption from FDA’s normal enforcement regime.
- Importers who believe their products may fall into CSMS Category 3 are encouraged to closely review the relevant guidance documents (linked above) to ensure the product meets all applicable criteria.
There have been frequent developments related to the regulation of products in each of these categories, and FDA policies may continue to evolve. Although following the steps outlined in the updated CSMS will help reduce certain challenges in the import process, given the high volume of anticipated imports and the highly nuanced and rapidly evolving FDA guidance on a wide range of products, stakeholders may nevertheless encounter impediments.
If you have any questions regarding these developments and their implications, please contact any member of the DLA Piper International Trade group, or your DLA Piper relationship attorney.