Emergency Use Authorization for Respirators
U.S. FDA has authorized certain non-NIOSH-approved respiratorsA respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors. made in China for use in healthcare settings by healthcare personnel during the COVID-19 public health emergency. Under the Emergency Use Authorization (EUA), authorized devices are exempt from certain current good manufacturing practice requirements.
Registrar Corp can help you comply with FDA requirements for your device under the EUA. Simply complete the form below: