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

Flowchart image: 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?

YES: The respirator is authorized under the EUA for NIOSH-approved air-purifying respirators and can be distributed for health care use in the United States during the COVID-19 pandemic. All previously FDA approved or cleared respirators are NIOSH-approved. Respirators approved by National Institute for Occupational Health and Safety (NIOSH) are shown in the NIOSH Certified Equipment Lists (CEL) for non-powered air purifying respirators with particulate protection and PAPRs with particulate protection.
NO: The appropriate EUA pathway for your respirator is determined by the country in which the respirator is manufactured. Continue to the following question:

Will you be manufacturing in the United States?

Yes
- The respirator requires NIOSH approval or FDA clearance. Once NIOSH approval is obtained, the respirator will be authorized under the EUA for NIOSH-approved air-purifying respirators.
No
- If you are manufacturing in China, your respirator requires FDA clearance or must be authorized under the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China.
- If you are a foreign manufacturer not in China, your respirator requires FDA clearance or must be authorized under the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs).

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.