FDA Divides into Two its Guide on Face Masks

FDA has split into two its guidance entitled “Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).” The two new guidances have no changes to the agency’s enforcement policy, and the action is intended only to facilitate a different timeline and process for transitioning back to normal operations, as described in the Federal Register notice on this topic and on the Covid-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders Web page. The new guidances are:

• “Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency”
• “Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency”