FDA Issues EUA for Surgical Masks

HIDA is reporting that the FDA has issued an umbrella emergency use authorization for certain disposable, single-use surgical masks in response to concerns over insufficient supply during COVID-19. The EUA authorizes the emergency use of surgical masks meeting certain performance requirements for use in healthcare settings by healthcare personnel as personal protective equipment. To be added as an authorized surgical mask under this EUA, manufacturers must provide test reports that demonstrate that the surgical mask meets the performance criteria in the EUA and is not excluded. Manufacturers may request the inclusion of a surgical mask model by submitting a request to FDA.

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