FDA Grants EUA for General Purpose Face Masks and Continues to Address PPE Shortage

On April 18, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for face masks in its continuing effort to address shortages of the personal protective equipment (PPE). This most recent EUA applies only to general purpose face masks or “face coverings.”

The Centers for Disease Control and Prevention (CDC) announced its recommendation to wear cloth face coverings in public settings where social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies). For health care professionals, face coverings may be combined with other respirators (e.g., N95 NIOSH -approved respirators) to optimize the supply of face masks during the pandemic.

Face masks that are authorized under the April 18 EUA must conform to the list of requirements that FDA provides, which includes proper labeling. In addition, no printed matter relating to the use of the authorized face mask may represent or suggest that a face mask is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic.

Refer to the full text of the EUA for a complete description of requirements and responsibilities.

Since the advent of the COVID-19 public health emergency, FDA has granted the following PPE-related EUAs:

• NIOSH-approved respirators
• Imported non-NIOSH-approved respirators
• Non-NIOSH-approved respirators manufactured in China
• Face shields

FDA also has issued guidance on its enforcement discretion and temporary policies for face masks and respirators, gowns, other apparel, and gloves, and manufacturing hand sanitizers.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.