PPE Shortages: FDA and Chinese Government Issue New Policies for Masks, Gowns and Gloves

The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many U.S. distributors and end users are looking to import products from China.

This could be an effective solution for many stakeholders provided the arrangement complies with both U.S. and Chinese regulatory requirements. Both countries continue to update their relevant regulatory policies, with a number of changes announced since April 1, 2020.

The application of these regulations is product specific. Companies looking to import any PPE must perform the appropriate diligence on the regulatory treatment of the specific product that they intend to import.

FDA Importation Regulations for PPE

In the U.S., PPE is generally regulated by the U.S. Food and Drug Administration (FDA) as medical devices. Therefore, manufacturers must comply with medical device regulations, which include the FDA's rules on importation of devices.

Specifically, to lawfully import PPE, foreign manufacturers and initial importers must comply with two primary requirements:

1. Establishment Registration: Under FDA's regulations, establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S. are required to register annually with the FDA. This requirement applies to foreign manufacturers as well as domestic. In addition, initial importers of medical devices are also subject to establishment registration requirements. Initial importers have 30 days after importation to register their establishments. Registration can be done online through the FDA template and portal.
2. Product Listing: Establishments are also required to list the specific devices manufactured for importation into the U.S. and the activities performed (such as foreign manufacturer, specification developer, initial importer) on those devices at that establishment. Therefore, both foreign manufacturers and initial U.S. importers are required to list the devices. Foreign manufacturers must properly list any device that is being sent for import into the U.S. before the device may be imported into the U.S. Note that U.S. distributors are generally exempt from FDA's establishment and listing requirements (if they are not the initial importer).

New FDA Enforcement Policies for PPE

In response to the COVID-19 pandemic and the recognized shortage of PPE, FDA has recently developed new enforcement policies to try to expedite the importation of these products.

• Masks and Respirators: Regarding masks and respirators, FDA released an enforcement policy allowing these products to be imported and distributed in the U.S. under certain circumstances even if the proper device Establishment Registration and Product Listing requirements have not been met. Specifically, FDA applies a risk-based standard that says that the device can be imported if it does not "create an undue risk in light of the public health emergency." The agency specifies the criteria to be used when applying this policy, though generally the key aspects are the content of the product label, the product's intended use and whether it is meant to provide "liquid barrier protection."
• Gowns: FDA's enforcement policy reiterates that only gowns that are intended for a medical purpose, including for use by healthcare professionals, are regulated medical devices. FDA distinguishes between "Surgical Gowns" and "Non-surgical Gowns and Minimal-to-Low Barrier Protection Surgical Apparel." In general, FDA recommends that healthcare providers follow current Centers for Disease Control and Prevention (CDC) guidance regarding PPE that should be used during the COVID-19 pandemic. Similar to its policy on masks and respirators, FDA policy says the agency does not intend to object to the distribution and use of gowns that do not comply with Establishment and Listing requirements where the gowns and apparel do not create an undue risk in light of the public health emergency.
• Gloves: As with gowns, FDA regulations apply only to gloves (the agency distinguishes between "Patient Examination Gloves" and "Surgeon's Gloves") intended for a medical purpose. FDA also recommends that healthcare providers follow CDC guidance regarding use of gloves during the COVID-19 pandemic. In addition, FDA applies a similar risk-based analysis to determine whether the Establishment Registration and Product Listing requirements can be waived.

China's New Regulatory Policy for COVID-19 Exports to the U.S.

Very recently, China imposed more restrict control on exporting PPEs combating COVID-19. Last week, China's Ministry of Commerce (MOFCOM), General Administration of Customs (GAC) and National Medical Products Administration (NMPA) released a new regulation to regulate the export of medical supplies from China amid the COVID-19 crisis. Starting April 1,2020, when entities that export coronavirus detection reagents, medical masks, medical protective clothing, ventilators and infrared thermometers declare their products to U.S. Customs and Border Patrol, they must provide a written or electronic document stating that the products have obtained China's Medical Equipment Product Registration Certificate and at the same time meet U.S. regulatory and quality standards.

The new regulation was triggered by the complaints from governments of three European countries through high-level diplomatic channels. No products without NMPA approval can be exported from China. The Chinese customs and ports authorities have been vigorously enforcing this regulation and carefully inspecting all products to prevent non-compliant products from leaving the borders of China.

Holland & Knight's attorneys have extensive experience in both FDA's and China's medical device laws and regulations. The situation is fluid and changing daily. For questions about a situation specific to your healthcare organization, please contact the authors.

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the author of this alert for timely advice.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem. Moreover, the laws of each jurisdiction are different and are constantly changing. If you have specific questions regarding a particular fact situation, we urge you to consult competent legal counsel.