Posts Tagged ‘#FDA’

Surgical Mask EUA During the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for certain Personal Protective Equipment (PPE), including Surgical Masks.  Normally a FDA 510K Premarket Notification is required prior to marketing a mask as a Surgical Mask.  This is still a long term requirement.  However, due to the issuance of the Umbrella…