COVID-19 Update: FDA Updates on Face Masks and Respirators

FDA Updates on Face Masks and Respirators During COVID-19

Enforcement Policy for Face Masks and Respirators (Revised) On April 2, 2020, the FDA revised an immediately in effect guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 and KN95 respirators) for health care professionals during this pandemic.  This guidance updates the previous version of the guidance published on March 25, 2020.  This update provides recommendations regarding face shields, surgical masks, and alternatives, which may include KN95 respirators, when FDA-cleared or NIOSH-approved N95 respirators are not available.

Read the guidance New Emergency Use Authorization (EUA) On April 3, 2020, the FDA issued a new EUA specifically for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China. Under this EUA, authorized respirators listed in Appendix A are authorized for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak. Read more on the EUA New FAQ on KN95s On April 3, 2020, the FDA posted a new FAQ on KN95s: Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic? Short answer: Yes, if in accordance with certain criteria. Read the FAQ Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.