The Food and Drug Administration imposes an extensive and time-consuming qualification process for medical devices. While that may be a virtue in normal times, to ensure that such products meet safety and quality standards, it can stand as a roadblock when increased volumes are needed on short notice.
Recognizing that current supplies of face masks and other personal protection equipment are inadequate in the face of the COVID-19 pandemic, the FDA has adopted a new Enforcement Policy and Emergency Use Authorization allowing importers, as well as domestic suppliers, to bypass most of the regular qualification steps. Since I’m most familiar with the face masks requirements, I will focus on them.
As a starting point, the FDA asserts jurisdiction only over face masks intended for medical use. Those for industrial and construction applications are excluded. In which group do face masks for general COVID-19 avoidance uses fall? For example, in DC and Maryland, we are required to wear masks in food markets and on public transportation. Are these medical uses, so that such masks fall within FDA rules?
The agency’s position is that “Face masks, face shields, and respirators are devices when they are intended for a medical purpose, such as prevention of infectious disease transmission (including uses related to COVID-19).” The EUA also indicates that it applies “to the use of face masks for use by members of the general public, including HCP in healthcare settings as PPE, to cover their noses and mouths, in accordance with CDC recommendations, to prevent the spread of the SARS-CoV-2 during the COVID-19 pandemic.” This broad coverage encompasses face masks used by the public for day-to-day activities.
Between them, the Enforcement Policy and EUA exempt qualifying face masks from pre-market notification, registration, quality system and labeling and unique identifier requirements. To qualify, an article must meet specific labeling requirements. The manufacturer must have a “process in place for reporting adverse events of which they become aware”, and manufacturers and distributors must maintain records. There also are conditions imposed on advertising and promotion of the products. Of course, once the COVID-19 emergency is terminated (if ever), the old rules will kick back in.
The FDA has followed a similar approach for other protective items, such as face shields and respirators. Product definitions are crucial in determining how a product is treated. For example, a face mask is defined as “A mask, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels.” I’m pretty sure this doesn’t cover the bandanas I use as face coverings in my local Safeway. Face shields and surgical masks have their own definitions and requirements.
Importers and distributors of personal protection equipment now have an opportunity to supply the United States market on an expedited basis, but must be sure to follow the relaxed rules to avoid problems with FDA and Customs and Border Protection.