EUA - Emergency Use Authorization: FDA's relaxed import procedure of and protective equipment

18/10/2020

Authorization and import permits United States

FDA regulation to import surgical masks in the United States

What are the authorization and permit needed to export surgical masks to America?



FDA compliance masks



Compliance requirements for face masks have been relaxed to cope with the COVID-19 emergency

The FDA now allows to request an Emergency Use Authorization [EUA] to speed up the import procedure of some types of masks

FDA compliance varies according to the classification of the various types of protective equipment. In fact, "Mask" is a generic term and the FDA adopted a much more comprehensive classification to include "Masks" with different claims and features. On this page you can find all the definitions used by the FDA to identify masks and similar protective equipment.

  • Face Mask
    A mask, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks are for use by the general public and HCP only as source control in accordance with CDC recommendations.

  • Face Shield
    A face shield is a device used to protect the user's eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. Generally, a face shield is situated at the crown of the head and is constructed with plastic to cover the user’s eyes and face.

  • Surgical Mask
    A mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests.

  • Filtering Facepiece Respirator
    A filtering facepiece respirator (FFR) is a device that is a disposable half-face-piece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates.

  • N95 Respirator
    A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level. Such an N95 FFR used in a healthcare setting is regulated by FDA (FDA product code MSH) and is either a class II device that is exempt from premarket notification requirements under section 510(k) of the FD&C Act or is a class II cleared device.

  • NIOSH Approved N95 Respirator
    An N95 respirator, approved by NIOSH that meets filtration efficiency level.

  • Surgical N95 Respirator
    A disposable FFR used in a healthcare setting that is worn by HCP during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level.




The path to compliance of a medical device varies according to its classification

FDA classification as medical device for all the different types of face masks

  • Mask, Surgical = FXX

  • Pediatric/Child Facemask = OXZ

  • Accessory, Surgical Apparel (Face Shield) = LYU

  • Surgical mask with antimicrobial/antiviral agent = OUK

  • Respirator, Surgical = MSH

  • N95 Respirator with Antimicrobial/Antiviral Agent = ONT

  • N95 Respirator with Antimicrobial/Antiviral Agent for Use by the General Public in Public Health Medical Emergencies = ORW

  • Respirator, N95, for Use by the General Public in Public Health Medical Emergencies = NZJ 


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