FDA Update

It took awhile but we saw this coming – the EUAs will be ending.

Further Guidance Clarification Post COVID Just Announced by FDA

Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators

Today, the U.S. Food and Drug Administration (FDA) divided into two the guidance, 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 enforcement policy:

• 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

This division of the previous version of the guidance does not affect the current policy and is intended only to facilitate a different timeline and process for transitioning back to normal operations, as further described in the Federal Register notice on this topic.

As noted in the Federal Register notice, the FDA is helping to provide clarity to stakeholders with respect to the guidance documents and the termination of the public health emergency (PHE) declaration.

• The Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency guidance will be withdrawn 180 days after the PHE terminates.
• The Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency will be revised and replaced within 180 days after the PHE terminates.

Want to market these devices you need to get 510(k). mdi can assist you with this process.

Questions?

For more information on Face Shields, Surgical Masks, and Respirators, Face Masks, and Barrier Face Coverings please email us at: [email protected] and ref: Face Shields, Surgical Masks, and Respirators, Face Masks, and Barrier Face Coverings.