The FDA’s Enforcement Policy for Face Masks and Barrier Face Coverings for Coronavirus Disease (COVID-19) Response guidance update was published on September 5th, 2023. By updating the regulatory expectations of face masks and barrier face coverings, this guidance increases the availability of such medical devices to the general public and those working in health care settings where appropriate.
In the revised guidance the FDA intends to help stockpiles of face masks and barrier face coverings to continue being sold and used where appropriate when EUA’s for those devices have been revoked. If manufacturers and devices meet specific criteria the FDA believes that their continued supply in the market is appropriate and does not create undo risk. Those that manufactured face masks and filtering facepiece respirators (FFR’s) can continue to sell their inventory for the foreseeable future.
For assistance familiarizing your company with the new guidance and ensuring your company continues to place these devices on the market appropriately, contact DPDC to start planning! Reach out now for a free consultation.
To see the document recently published by the FDA regarding the updated guidance, click here.