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  6. Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic
  1. Coronavirus (COVID-19) and Medical Devices

Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic

This flowchart provides information on manufacturing and distributing respirators for health care use in the United States under an existing emergency use authorization (EUA) during the COVID-19 public health emergency. It also provides links to detailed information provided by the FDA, the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH).

Is the respirator designed to be a disposable Filtering Facepiece Respirator (FFR) (such as, N95)?

  • NO: The product is a reusable respirator such as an elastomeric or powered air purifying respirator (PAPR). To market and distribute these reusable respirators for health care use in the United States, the respirator requires NIOSH approval and once approval is obtained will be authorized under the EUA for NIOSH-approved air-purifying respirators.
  • YES: Continue to the following question:

Do you have NIOSH approval?

Will you be manufacturing in the United States?

For information on importing products, refer to Information for Filing Personal Protective Equipment and Medical Devices during COVID-19.

Note: For information about the types of filtering facepiece respirators (FFRs) for health care use, including disposable N95s, reusable elastomeric respirators, and reusable powered air purifying respirators (PAPRs) see the FDA’s N95 Respirators, Surgical Masks, and Face Masks and the CDC’s Respirator Trusted-Source Information.

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