Recently, the United States Food and Drug Administration (FDA) eased some requirements to allow for more access to masks, personal protective equipment (PPE), and respirators in response to the COVID-19 pandemic.
Relaxed Guidelines on Importation of PPE and Masks
On March 24, 2020, the FDA issued guidance that reduced the amount of information that needs to be submitted in the entry process for PPE and other devices that are intended for emergency use or covered by an enforcement discretion policy.
Under the guidance, for non-FDA regulated PPE that is intended for general or industrial use, that entry information should not be sent to the FDA, but instead importers should transmit the information to United States Customs and Border Protection (CBP). In that case, importers should use the appropriate harmonized tariff schedule (HTS) code for the product – either without an FD flag or with an FD1 flag and “disclaim” for FDA.
For products that are covered by an emergency use authorization (EUA), importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use and the appropriate product code for the device. This includes diagnostics, masks, and respirators.
In addition to the above guidance, on March 28, 2020, the FDA issued an EUA for certain respirators that are not approved by the National Institutes of Occupational Safety and Health (NIOSH) from six countries: Australia, Brazil, Europe, Japan, South Korea, and Mexico. Respirators can also qualify for import under this EUA if they have a CE mark, or if they are authorized by regulators in Australia, Canada, or Japan. In order to qualify under this EUA, however, manufacturers and importers must first submit a request to the FDA and demonstrate that their respirators meet the criteria. Companies can also submit EUA requests if they wish to import non-NIOSH approved respirators that do not meet the EUA criteria.
FDA Relaxes Guidance on Masks and Respirators
On March 25, 2020, the FDA also released guidance (revised in April 2020) that lifted requirements for certain masks and respirators, to allow for increased availability. In the guidance, FDA indicated that there are many products marketed as face masks throughout the country and that face masks and respirators are only regulated by the FDA when they meet the definition of a device in the Federal Food, Drug, and Cosmetic (FD&C) Act. This means that FDA-regulation of face masks is typically reserved for face masks used with an underlying intent of a medical purpose, not when they are intended for general or industrial use.
In the guidance, the FDA acknowledges that “when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improve PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.” To that end, for face masks that are intended for a medical purpose but are not intended to provide a liquid barrier protection, the FDA is lifting regulatory requirements to increase the availability of the devices, including: 510(k) submission, quality system registration (QSR), and unique identifier requirements, provided that the devices do not create an undue risk for users.
According to the guidance, the FDA will allow the distribution and use of surgical masks without 510(k) clearance, as long as the masks meet certain standards for fluid resistance and flammability, and include accurate labeling.
Also, as mentioned by President Trump multiple times, the FDA is looking into allowing companies to disinfect and reprocess disposable N95 masks to stretch the supply under an EUA. The FDA is willing to work with companies on expediting the EUA process – working around the usual requirement of obtaining 510(k) clearance to reprocess single use devices – and provides an extensive list of information (p.9 and 10) for companies to submit to submit their EUA request.
These relaxed guidelines are expected to help ease some of the burden the healthcare system is feeling; however, they only apply to specific masks and respirators, as outlined on page 3 of the guidance.