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Compliance In Focus
Posted by Amy Rooks on Fri, Apr 10, 2020

FDA Regulation of Face Masks and Respirators During the Pandemic

Last month, the Department of Health and Human Services estimated that the United States only had about 1% of the N95 respirators that would be required for medical professionals during the COVID-19 pandemic. 

Face Masks and Respirators-2

The Assistant Secretary for Preparedness and Response, Dr. Robert Kadlec, while testifying before the Senate Committee on Health Education, Labor and Pensions, noted that “if it were to be a severe event, we would need 3.5 billion N95 respirator masks. We have about 35 million.” As hospitals across the country are struggling to obtain the appropriate personal protective equipment (PPE) for their providers, we are going to take a look into the FDA’s role in the regulation of these devices and the latest steps they have taken to increase the available supply during this pandemic.

Are facemasks and respirators considered medical devices?

It depends. Facemasks and respirators meet the definition of a device and fall under FDA regulations when “intended for a medical purpose” (including the cure, mitigation, treatment, or prevention of disease). Facemasks and respirators marketed for non-medical purposes (construction for example) are not regulated by the FDA.

Surgical masks (facemasks) and N95 respirators (a type of filtering facepiece respirator) are the two most common types of masks that you have likely heard about regarding healthcare use as PPE against the novel coronavirus. Surgical masks come in several different types, but are considered a loose-fitting, disposable device designed to prevent large-particle droplets from the wearer. A filtering facepiece respirator (FFR) is a disposable, tight-fitting device designed with a more efficient particle filtration to reduce exposure to smaller particles. An N95 respirator is able to filter at least 95% of 0.3 micron particles in the air (including microorganisms). Both surgical masks and surgical N95 respirators (for use in healthcare settings) are considered class II medical devices and are regulated by the FDA under 21 CRF 878.4040. However, surgical N95 respirators are also regulated by the CDC National Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part 84.

FDA Emergency Use Authorizations (EUAs) for COVID-19

The FDA recently released an extensive guidance document providing conditions to the policies in effect only during this COVID-19 public health emergency, with the intent to increase the availability of masks and respirators for U.S. healthcare personnel. Some of the most notable items in the EUAs for personal respiratory protective devices include:

  • All disposable NIOSH approved FFRs have been authorized for use in healthcare settings. This now allows respirators not meeting the definition of a device (for example FFRs marketed for industrial use) to be distributed in healthcare settings.
  • Non-NIOSH approved FFRs meeting certain criteria under the EUA are now deemed by the FDA as appropriate in order to protect the public health or safety. This allows the import of certain disposable FFRs which have been validated by outside regulatory jurisdictions into the U.S. for immediate use.
  • NIOSH approved FFRs that are expired, if they are not damaged and were held in accordance with the manufacture’s storage conditions, are now authorized for use. This will allow the use of expired FFRs from strategic stockpiles to be distributed to healthcare facilities.
  • Certain disposable FFRs that “have been decontaminated using an authorized decontamination system” are now cleared for use. This allows the Battelle Memorial Institute to begin using their decontamination system at locations with insufficient supplies, in compliance with the multiple criteria noted by the FDA in the EUA.

The FDA released the guidance document and EUAs with the intent to ease the regulatory burden on manufacturers and importers to quickly increase the supply of available PPE for our healthcare workers. An EUA for ventilators was also released containing additional information. The FDA further notes that they are open to collaboration with manufactures of items not covered in the current EUAs. Companies are encouraged to consult with and provide to the FDA the required information noted in the guidance to assess device eligibility for additional device-specific EUAs. The FDA assured to “expeditiously review to determine if device can be used under EUA” and offered expediated reviews of premarket submissions, if needed. When determining what the current PPE guidance for COVID-19 is, it is important to remember that the CDC is responsible for infection control measure recommendations and not the FDA.

Do you consider these actions from the FDA to be significant enough to combat the current shortage of masks for healthcare personnel during the COVID-19 pandemic?


photo credit: Prachatai covid-19 via photopin (license)

Topics: FDA Regulations, COVID-19


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