The Food and Drug Administration (FDA) issued on April 9, 2020 its first emergency use authorization (EUA) for face shields to address the significant shortage of personal protective equipment (PPE) during the COVID-19 pandemic. This EUA applies to all face shields that comply with the EUA.
Face shields for use by health care professionals (HCP) as PPE are authorized under the EUA when they are intended for use by HCPs as PPE in health care settings in accordance with Centers for Disease Control and Prevention (CDC) recommendations. When no facemasks1 are available, CDC recommends using a face shield that covers the entire front (that extends to the chin or below) and sides of the face with no facemask to provide barrier protection. EUA-authorized face shields are required to meet the following requirements:
- The product is labeled as a face shield for medical purposes and lists body contacting materials.
- The label must accurately describe whether the face shield is for a single user, single use or for multiple uses by the same user, and include instructions for recommended cleaning and/or disinfection materials and processes, if applicable.
- It must not contain any flammable materials or must meet Class I or II flammability requirements per 16 CFR 1610.
- The product is not intended for any use that would create an undue risk. For example, the labeling should not claim use of the face shield alone will prevent infection from microbes or viruses or that it is effective against radiation protection.
Manufacturers of EUA-authorized face shields do not need to take any actions, other than complying with the requirements of the EUA. Manufacturers will be notified of the inclusion of their face shields as authorized face shields under this EUA through FDA’s posting and public announcement of this EUA at FDA’s website for PPE EUAs.
Manufacturers must comply with the Conditions of Authorizations (Section IV) to be an authorized face shield. Manufacturers must:
- Provide a letter to each end-user facility with compliant labeling discussed above
- Provide instructions to each end user facility for recommended cleaning and/or disinfection materials and processes, if applicable
- Establish a procedure for reporting adverse events, maintain any records associated with the EUA and maintain distribution records (e.g., name of entities and number of products)
- Ensure all communications are consistent with the labeling required of the EUA and any additional information related to the emergency use of their product is consistent, but does not exceed, the EUA
- Refrain from making any claims or suggestions that their product is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic
- Ensure all promotional materials clearly and conspicuously state: (1) the product has not been FDA cleared or approved, (2) the product has been authorized by FDA under an EUA for use by health care providers as personal protective equipment and (3) the product is only authorized for the duration of the COVID-19 national emergency.
In addition, FDA has waived certain regulatory requirements for authorized face shields:
- Applicable current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820
- Labeling requirements, including unique device identification requirements (see Subpart B of 21 CFR Part 801), except that face shields must include the labeling elements specified in the EUA
Over the past several weeks, FDA has issued multiple EUAs for various PPE. This is another step by FDA to extend EUA for PPE and to give health care workers access to equipment while providing manufacturers with benefits available under the EUA.
Refer to the full text of the EUA for a complete description of responsibilities.
- Face masks are 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.” FDA, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), p. 4.
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.