FDA’s Emergency Authorization of Face Masks

On April 18,2020 RADM Denise M. Hinton, Chief Scientist of the FDA issued a letter giving the statement in which facemasks are authorized for Health Care Professionals. However, she re-issued the April 18,2020 letter to incorporate and clarify the emergency authorization of facemasks used by the general public to cover nose and mouth, following the CDC recommendations to control the spread of viruses.

It’s important to understand the FDA gave authorization for facemasks to be used as a control method and is not an FDA approved method to cure any type of disease.

The criteria (under Section 564(c) of the act) used by the FDA to determine this emergency authorization and help prevent the spread of the virus during the current COVID-19 pandemic is:

  1. SARS-CoV-2, the virus that causes COVID-19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
  2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the authorized face masks may be effective as source control to help prevent the spread of SARS-CoV-2 by infected individuals who may or may not have symptoms of COVID-19 during the COVID-19 pandemic, and that the known and potential benefits of face masks, when used in accordance with the scope of this authorization (Section II), outweigh the known and potential risks of such product; and
  3. There is no adequate, approved, and available alternative to the emergency use of face masks for source control by the general public and for HCPs to help prevent the spread of the virus due to face mask shortages during the COVID-19 pandemic.1,2

Types of FDA Authorized Face Masks

Included in the re-issued letter, RADM Denise Hinton Chief Scientist of the FDA shares the type of face masks authorized for general public and Health Care Professionals must meet the following requirements:

  • The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials (which does not include any drugs or biologics);

  • The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection;

  • The product labeling includes recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high;

  • The product is not labeled in such a manner that would misrepresent the product’s intended use; for example, the labeling must not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction;

  • The product is not labeled as a respiratory protective device, and therefore should not be used for particulate filtration; and

  • The product is not labeled for use in high risk aerosol generating procedures.3

FDA’s Conditions of Authorization for Face Masks

RADM Denise Hinton Chief Scientist of the FDA established certain conditions to the emergency authorization of Face Masks according to the Section 564(e) of the Act:

Manufacturers and Distributors of Authorized Products4:

  • Manufacturers and Distributors will make face masks available with labeling that includes a description of the product as a face mask, including a list of the body contacting materials (which does not include any drugs or biologics).
  • Manufacturers and Distributors of authorized products shall not label the product: 1) as a surgical mask, to provide liquid barrier protection; 2) for use in a clinical setting where the infection risk level through inhalation exposure is high; 3) for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses; 4) as a respiratory protective device; or 5) for high risk aerosol-generating procedures.
  • Manufacturers must make the required labeling available to each end user or end user facility (each hospital) in hard copy or in an alternative format (e.g., electronic labeling on the manufacturer’s website). Instructions on how to access the labeling if provided in an alternative format must be available to each end user or end user facility.
  • Manufacturers and Distributors will include instructions for recommended cleaning and/or disinfection materials and processes, if applicable, for their authorized product(s). Manufacturers must provide these instructions, if applicable, to each end user or end user facility (e.g., each hospital) in hard copy or in an alternative format (e.g., electronic instructions). Instructions on how to access the labeling if provided in an alternative format must be available to each end user or end user facility.
  • Manufacturers will have a process in place for reporting adverse events of which they become aware to FDA under 21 CFR Part 803. Adverse events of which the manufacturer becomes aware will be reported to FDA. See FDA’s webpage “Medical Device Reporting (MDR): How to Report Medical Device Problems”5 for reporting requirements and procedures.6
  • Manufacturers and distributors will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.
  • Through a process of inventory control, manufacturers and distributors will maintain records of the entities to which they distribute the face masks and the numbers of each such product they distribute.
  • Manufacturers and distributors are authorized to make available additional information relating to the emergency use of the product that is consistent with, and does not exceed, the terms of this letter of authorization.

¹No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

²Providing authorization for the introduction into interstate commerce of face masks by manufacturers that do not customarily engage in the manufacture of medical devices helps meet the needs of the healthcare system. In addition, increased availability of face masks helps meet the needs for source control for the general population, reserving FDA-cleared surgical masks and FDA-cleared or -authorized N95 and N95 equivalent Face Filtering Respirators for use by HCP. Providing HCP who are on the forefront of the COVID-19 response with sufficient PPE is necessary in order to help prevent HCP exposure to pathogenic biologic airborne particulates during the COVID-19 pandemic.

³Examples of aerosol generating procedures in healthcare settings may be found at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html

⁴The requirements under 21 CFR Part 806 (Reports of Corrections and Removals) and 21 CFR Part 807 (Registration and Listing) do not apply to products authorized under an EUA. As such, compliance with these regulations are not required under this EUA.

⁵FDA guidance, titled “Medical Device Reporting (MDR): How to Report Medical Device Problems” is available at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

⁶Also refer to FDA guidance, titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” available at https://www.fda.gov/media/72498/download.