As this COVID-19 pandemic persists, all of us have seen in the news stories of shortages of critical personal protection equipment (PPE) to protect our first responders and healthcare professionals, as well as shortages of critical equipment such as ventilators for patients who have succumbed to the disease. This brings up an inner calling on many of us to ask ourselves, what can I do? How can I help source PPE and other critically needed medical devices?
Many of our clients are doing great work to combat the shortages by leveraging existing expertise and connections to source PPE and other critically needed medical devices, often from outside the United States. A noble endeavor, however, an altruistic purpose will not prevent enforcement action by federal and state regulators who have the responsibility to protect the United States consumer from fraudulent or ineffective PPE and other medical devices. Our clients need to be wary of fraudsters looking to take advantage of their eagerness to help out a nation in need.
This article provides a basic overview of the regulatory requirements, which if not met could land our clients' otherwise well-intended attempt to source PPE in a whole lot of hot water.
First and foremost, we must determine if our client's action with respect to sourcing the PPE or other medical devices requires registration with the FDA as an "initial importer." The FDA defines an initial importer is as follows: “Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes 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. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.” If you are an "initial importer", FDA registration is required.
The links for how to complete this registration and related information can be found here and here. The annual fee is $5,236. If there is a question as to whether you are required to complete this registration, a helpful link can be found here. We are able to assist in completing the registration for any clients that might be considering importing PPE or other critically-needed medical devices.
It is equally important to vet the PPE and other medical devices, and the manufacturers of such PPE and medical device, which our clients are interested in importing and distributing within the United States. This due diligence requires confirming if the manufacturer and product were FDA approved, or if not FDA approved, authorized by meeting the requirements of an Emergency Use Authorization (“EUA”) for use in the United States. Since emergency declarations have been made by local, state, and federal governments related to the COVID-19 pandemic, many EUAs have been issued with the objective of helping meet the nation’s current needs without artificially creating regulatory and legal roadblocks for otherwise effective and high-quality medical devices. The challenge, however, is that there are multiple EUAs covering various medical devices, including PPE.
The requirements and specifications vary considerably from one EUA to the next, and there are different EUAs depending on not only the type of device you are seeking to import but also from which country you are seeking to import the device from. Further, there are different enforcement guidelines pertaining to different devices. When a manufacturer and device are approved through the EUA process there is an Appendix published and updated every few days so that this information is transparent and available to the public. As examples, below we have included links where you can see approved respirators specifically coming in from China, and approved ventilators:
- Authorized Respirators (from China - including KN95s)
- Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
Additional considerations to perform due diligence on are: (i) if an exporter is involved in the country of origin of the devices if they meet the requirements of the country of origin for export, and (ii) the laws and regulations which may exist at the state level for purposes of the manufacture and distribution of medical devices.
The products liability risk profile is particularly high with respect to importing or distributing PPE and other medical devices under an EUA. It is important to note that while operating under an EUA will generally prevent enforcement action by the FDA (except in cases of fraud, misrepresentation, and other intentional bad acts), compliance with an EUA does not prevent civil liability from a hospital, health care provider, or patient, if the PPE or other medical device being imported, sourced or distributed is fraudulent or defective.
Pursuant to an EUA, the FDA approves of a medical device on an emergent basis and without going through the FDA’s normal vetting processes. The EUA furnished a new market from which to source PPE and other medical devices, and the COVID-19 health emergency created unprecedented demand both domestically and abroad. While this article presupposes an altruistic intent, the fact remains that importing, sourcing and distributing PPE and other medical devices in the current climate can be a lucrative endeavor. It is important to be wary of who our clients are engaging with in these transactions, as there are many new players dabbling in the manufacture, importation, and distribution of PPE and other medical devices. The combination of new and evolving regulations, extreme demand, emergent time pressures, and inexperienced operators is a landmine.