As efforts continue in the United States to prepare for and treat a growing wave of COVID-19 patients, healthcare providers, first responders and others have been confronted with severe disruption to the global supply of personal protective equipment (PPE). Limited access to critical supplies such as masks, respirators, gloves, goggles, face shields, gowns and aprons required by physicians, nurses and others to provide care to COVID-19 patients has spawned efforts by various stakeholders in the U.S. to explore sourcing these products from overseas manufacturers.
Organizations wishing to explore importation of these products into the U.S. should be mindful that many of these products, when used by healthcare providers in healthcare settings, are classified as medical devices by the U.S. Food and Drug Administration (FDA). In addition, these entities should be aware of possible customs and tariff issues arising from such activities. This alert provides a summary of these issues, but we encourage entities considering the importation of these types of PPE products to consult their legal advisors to ensure compliance with applicable regulations.
FDA Classification of Medical Devices
The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: Class I, Class II or Class III.
Many items of PPE, such as gloves, medical masks, respirators, goggles, face shields, gowns and aprons reflect a relatively low degree of risk and therefore are classified as Class I medical devices by FDA. Further, because many types of PPE fall into a generic category of exempted Class I devices, premarket notification application and FDA clearance are not required before marketing the device in the U.S.
We caution, however, that exemption from FDA premarket requirements occurs on a product by product basis, and FDA more recently has issued exemptions for certain devices. For example, on March 24, 2020, FDA issued an Emergency Use Authorization (EUA) allowing for the importation and emergency use of certain non-NIOSH-approved “filtering face-piece respirators” (FFRs) for use in healthcare settings by healthcare professionals when used in accordance with CDC recommendations to prevent exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak. This EUA facilitates the importation and distribution of FFRs manufactured in Australia, Brazil, Europe, Japan, Korea and Mexico (but not China). While FDA’s EUA designation waives applicable current good manufacturing practice requirements, including quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage and distribution of the authorized respirators, manufacturers and importers of such equipment are required to comply with additional conditions relating to labeling and notice requirements.
Despite the availability of Class I device exemptions or Emergency Use Authorizations, foreign manufacturers of these devices and importers bringing the devices into the United States for commercial distribution are nevertheless required to register with the FDA. Registration can be done online via FDA, or a number of other third-party consultants.
FDA Regulation of Device Importers
U.S.-based entities wishing to explore the importation of PPE for further distribution should be aware of several regulatory obligations imposed by FDA. FDA defines an initial importer as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper or labeling of the device or device package. (21 CFR 807.3(g)).
An initial importer of a medical device is required to comply with the following regulatory requirements:
- Establishment Registration.
- Medical Device Reporting.
- Reports of Corrections and Removals.
- Medical Device Tracking (as applicable).
The initial importer must have a physical address in the U.S. and is charged by FDA with ensuring the compliance of imported devices with all applicable FDA laws and regulations. Further, as part of the importer’s registration process with FDA, the importer is required to identify foreign manufacturers of the devices to be imported.
As a result, it is imperative for any entity wishing to import medical devices to conduct appropriate diligence on the products and manufacturers before seeking to import such products. Specifically, importers should confirm any foreign manufacturer’s compliance with applicable manufacturer requirements, as described further below.
If products do not meet FDA regulatory requirements, they may be detained upon entry by customs.
FDA Regulation of Foreign Manufacturers
Owners or operators of places of business involved in the production and distribution of medical devices intended for use in the U.S. also are required to register annually with the FDA. In addition to this so-called establishment registration requirement, most establishments also are required to notify FDA of the devices that are manufactured at its facility (the device listing requirements).
Foreign manufacturers are required to satisfy applicable FDA regulations with respect to its manufacturing activities. These regulatory requirements include:
- Establishment Registration.
- Medical Device Listing.
- Quality System.
- Premarket Notification (not required for many exempt PPE products).
- Medical Device Reporting.
Further, a foreign manufacturer is required to designate an agent in the U.S. as a part of its initial and updated registration information. A foreign manufacturing site is subject to FDA inspection, medical device tracking (if required) and adverse event reporting.
Customs and Tariff Issues
In an effort to facilitate importation of critical PPE, the U.S. government has already waived the China-specific tariffs on many PPE products. This exemption from elevated tariffs requires minor administrative documentation, but underlying baseline tariffs, while typically nominal, remain in effect.
At this time, there are no known changes with respect to specific expedited customs procedures in the U.S. as has been implemented in the European Union (so-called “green” lanes), but we understand that this approach is being considered.
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