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 In this section:

                COVID-19 Emergency Use Authorizations for Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

                        Blood Purification Devices EUAs
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
          In Vitro Diagnostics EUAs
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          Personal Protective Equipment EUAs
          Remote or Wearable Patient Monitoring Devices EUAs
          Respiratory Assist Devices EUAs
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          Other Medical Device EUAs Home
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          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical Devices
          Personal Protective Equipment EUAsCOVID-19 Emergency Use Authorizations for Medical Devices Personal Protective Equipment EUAs
  
  	
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    Print**November 8, 2023**- The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the *Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: *Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)* and *Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19),* which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?


Personal Protective Equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Guidance Documents (Medical Devices and Radiation-Emitting Products).

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products.

Table of Personal Protective Equipment (PPE) EUAs

Umbrella EUA for Surgical Masks
	N95 and Other Respirators EUAs
	Face Shields and Other Barrier EUAsFor information on EUAs that were previously issued but no longer in effect, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.


Umbrella EUA for Surgical Masks

On August 5, 2020, the FDA issued an umbrella EUA for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorized the emergency use of surgical masks that met certain performance requirements for use in healthcare settings by health care personnel (HCP) as PPE, to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.

On March 6, 2023, the FDA revised and reissued the umbrella EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer add surgical masks to Appendix A.

EUA Letter of Authorization - Umbrella EUA for Surgical Masks (Reissued March 6, 2023)
	Fact Sheet for Healthcare Personnel
	Appendix A: Authorized Surgical Masks
	Surgical Masks Removed from Appendix AAppendix A: Authorized Surgical Masks

The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

All authorized surgical masks in the table below (Appendix A) are assigned the QMF product code.

Date of Addition
			Manufacturer
			Authorized Product Name (including model numbers)11/19/2021
			EcoGuard Inc.
			Disposable Single Use 4-Ply Earloop, model EcoGuard A ECO0510/29/2021
			MOCACARE Corporation
			MOCACARE Surgical Mask (Level 3)
			Model number: BC100507/12/2021
			SurgiMac Manufacturing Inc.
			Surgical Mask (Model – MAC-6501)06/30/2021
			Thrace Polyfilms S.A.
			Surgical Masks Model PLF.IIR05/07/2021
			Altor Safety
			3 Ply Surgical Mask (Model # 62212)05/07/2021
			Health Pro Supplies Limited
			Medical Surgical Mask HP2723 (Large)

			Medical Surgical Mask HP950308/08/2020
			Outdoor Research
			Outdoor Research Surgical Mask model #OR215908/18/2020
			Venus Group, Inc.
			Venus Medical Grade Disposable Surgical Mask10/05/2020
			Hanesbrands, Inc.
			Hanes Surgical Mask 01, Small and Large10/08/2020
			WPT Corporation
			WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020)10/15/2020
			Brandix Apparel Solutions Limited
			Disposable Surgical Mask BRNDX-DSM-001-LARGE11/03/2020
			Fischer Manufacturing, LLC
			Heartland Health Surgical Mask11/06/2020
			EcoGuard Inc.
			Surgical Mask - Disposable Single-Use 4-Ply Earloop
			Model #: EcoGuard A ECO03

			Surgical Mask - Disposable Single-Use 4-Ply Tie-on
			Model #: EcoGuard A ECO0411/20/2020
			Rymco Medical
			Surgical Mask (Tie-On)
			Model #: IMABEU

			Surgical Mask (Earloop)
			Model #: IMSBEU12/09/2020
			Nomad Goods
			Nomad Surgical Mask N-MASK-312/10/2020
			MOCACARE Corporation
			MOCACARE Procedure Mask (Level 1)
			Model #: BC100301/22/2021
			Honeywell International Inc.
			Procedure Mask with Earloops
			Model #: 559250M D01/29/2021
			131co Inc.
			ARX Surgical Mask (Model number ARX1001)02/12/2021
			SIO International Wisconsin, Inc
			Sharp MQ-3050 Surgical mask; Foxconn MQ-3050 Surgical mask03/19/2021
			Cleveland Veteran Business Solutions
			CVBS Surgical Mask - Model Number: SM103/29/2021
			Protektair, Inc
			Protektair-3 Surgical Mask Model #: PSM-300003/30/2021
			PZero Innovations, Inc.
			PZero Surgical Mask Model Number: FM20PZ0004/06/2021
			Keeo Life Private Limited
			3PLY Surgical Mask KF-SM3-EL
			4PLY Surgical Mask KF-SM4-EL04/19/2021
			BLUETRACK, Inc.
			Healthcare Pro Surgical Masks
			S-3050-WH04/16/2021
			Manohar Filaments Private Limited
			3 Ply Surgical Mask
			MF-SM3-EH04/21/2021
			GRAFICA VENETA S.p.A.
			MASK MEDICA GV 2 GV2-GVII-20200704/28/2021
			Devshree International Pvt. Ltd.
			Hoplon Brand Disposable Single Use Surgical Masks Level 1 per ASTM F2100 H3SS04/29/2021
			Phoenix Quality MFG, LLC
			PQM LibertyAir Surgical MaskModel - S-9501-EUA04/29/2021
			Honeywell International Inc.
			Procedure Mask with Earloops (PM345 C)04/29/2021
			Honeywell International Inc.
			Procedure Mask with Earloops (PM345 D)04/29/2021
			Honeywell International Inc.
			Procedure Mask with Earloops (PM345 E)05/12/2021
			Lumensource, LLC
			Lumensource Surgical Mask Model # PKM-S201B05/21/2021
			Medtecs USA Corporation
			Medtecs Medical Mask (Model FM-140G)05/21/2021
			Filtra-Systems Company, LLC
			Filtra Systems Surgical Face Mask (Model number – 0605202)05/26/2021
			Linghe International co. Ltd.
			Linghe Disposable, Single-Use Surgical Mask (Model Number: Best02)07/01/2021
			Connecticut Mask Company, LLC
			CMC Surgical Mask 10 (Model - CMC 10; ASTM Level 1)
			CMC Surgical Mask 30 (Model - CMC30; ASTM Level 3)07/02/2021
			Sesa LLC
			Sesa Health Surgical Mask (Model Number - SH.PPE.SM.2L3)07/02/2021
			LM Surgical Mask
			3-ply level 3 Earloop - LM0787
			3-ply level 3 Head Straps - LM101910/28/2021
			DediCare Medical Solution LLC
			Surgical Mask, Model Number – SM310111/05/2021
			Mahe Medical Service GmbH
			Mahe Medical Disposable Surgical Face Mask with Earloops, Model 001-USA-E01/12/2022
			Sidra Medical Supply Inc.
			Sidra Surgical Face Mask AD3PL2WH01/14/2022
			Little Rapids Corporation
			Graham Medical® Surgical Masks – Model Numbers: 88037 & 8803801/14/2022
			Supermax Healthcare Canada – Supermax Medical
			Surgical Mask, Model Number – 213003/04/2022
			Supermax Healthcare Canada – Supermax Medical
			Surgical Mask, Model Number – 2110
			Surgical Mask, Model Number – 212001/18/2022
			SafeSource Direct, LLC
			SafeSource Direct Surgical Mask with Ear Loops (Model EUA3001)06/30/2022
			Delta Medco, LLC
			Delta Medco Disposable Surgical Face Mask with Earloops (Model DSM0001)07/07/2022
			ARCH MedTech, LLC
			ARCH MedTech Level 3 Surgical Mask – AMT-001L (Earloop)
			ARCH MedTech Level 3 Surgical Mask – AMT-002T (Ear Ties)09/02/2022
			PADM MedicalTM Procedural Masks with Ear loops
			Surgical Mask, Model Number – SL3P171002/07/2023
			Medplan Private Limited
			MED-2002-EL (50 pieces/box)02/09/2023
			MDT Medical Products
			MDT Medical Products 3PLY Mask

Surgical Masks Removed from Appendix A

These surgical mask models had been on the list of authorized surgical masks in Appendix A but no longer meet the EUA's scope of authorization and thus are no longer authorized and have accordingly been removed from Appendix A.

Date No
			Longer
			Authorized
			Manufacturer
			Surgical Mask Model(s) No Longer Authorized01/21/2021
			Premier Guard USA LLC
			Premier Guard USA Surgical Face Mask 20-1002-SFM302/02/2021
			EcoGuard Inc.
			Surgical Mask - Disposable Single-Use 3-Ply Earloop
			Model #: EcoGuard B ECO01

			Surgical Mask - Disposable Single-Use 3-Ply Tie-on
			Model #: EcoGuard B ECO0203/19/2021
			Homtex, Inc.
			Sovereign America Surgical Mask
			Model #: 2000SM1, Blue color06/15/2021
			Premium-PPE Amerishield
			Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S07/23/2021
			Altor Safety
			3 Ply Surgical Mask (Model #62222)09/03/2021
			Altor Safety
			4 Ply Surgical Mast (Model #62232)03/30/2022
			INTAI Technology CORP
			INTAI SURGICAL MASK (non-sterile) - ASTM Level3
			(Model 9W001200)

			INTAI SURGICAL MASK (non-sterile) - ASTM Level3
			(Model 9W001201)12/16/2021
			Liberty Mask, LLC
			LM Surgical Mask Level 3

			LM Surgical Mask Level 206/14/2023
			PADM Medical Inc.
			PRECISION ECOTM Compostable / Plant Based Procedural Mask with Earloops (black - 100195, white - 100196)09/27/2023
			KNH Enterprise Co., Ltd.
			KNH Surgical Face Mask 
			Model Numbers:  
			902E1 (Ear Loop Level 1 – inner loop) 
			902E1-1 (Ear Loop Level 1 – outer loop) 
			902E2 (Ear Loop Level 2 – inner loop) 
			902E2-1 (Ear Loop Level 2 – outer loop) 
			902D1-M (3D Level 1 – size M) 
			902D1-L (3D Level 1 – size L) 
			902D2-M (3D Level 2 – size M) 
			902D2-L (3D Level 2 – size L) 
			902Z1 (Z-Folded Level 1) 
			902Z1 (Z-Folded Level 2)09/27/2023
			Honeywell International Inc.
			Procedure Mask with Earloops
			Model #: 559250M, 559250M B and 559250M C09/27/2023
			Danameco Medical Joint Stock Corporation
			D-Care Surgical Face Mask 3 ply (white), TAMMY Surgical Face Mask 3 ply (white)
			Model/AMIS Numbers: KTY60WK050, KTY75WK050, KTY74WK050

N95 and Other Respirators EUAs

The table below includes information about respirators authorized for emergency use by healthcare personnel during the COVID-19 public health emergency.

Date EUA Issued
			PPE (Letter of Authorization)
			Other Documents03/28/2020
			NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency
			EUA Clarification Letter on Respirators

Face Shields and Other Barrier EUAs

On May 1, 2020, the FDA issued an umbrella EUA for emergency use of protective barrier enclosures by HCP when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in health care settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE. The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revised or revoked when the criteria under section 564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for issuance of such authorization are no longer met, or other circumstances make such revision or revocation appropriate to protect the public health or safety.

On August 20, 2020, based on FDA's continued review of the scientific evidence available, the FDA revoked the umbrella EUA on the grounds that the criteria under section 564(c) of the Act for issuance of an EUA are no longer met and that revocation was appropriate to protect the public health or safety (see section 564(g)(2)(B)&(C) of the Act), and that individualized consideration of each EUA request for protective barrier enclosures would better protect the public health.


Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials. Availability of certain PPE are an integral part of routine patient care during the COVID-19 pandemic. The table below includes authorization information about the use of authorized face shields and other barriers for use during the COVID-19 public health emergency.

Date EUA Issued
			PPE (Letter of Authorization)
			Other Documents
			Procode Assigned05/04/2021
			ISOCUBE SS and ISOCUBE ONE
			Fact Sheet for Healthcare Personnel
				Fact Sheet for Patients
				ISCOCUBE SS:  Instructions for Use Healthcare Personnel and Facilities
				ISCOCUBE One: Instructions for Use Healthcare Personnel and Facilities
			QLE04/09/2020
			Face Shields
			None
			QPK05/08/2020
			Patient Isolation Transport Unit (PITU) Device
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				PITU Set Up and Operation Guide
				PITU User Manual
			QLE05/27/2020
			Gowns and Other Apparel
			None
			QZT06/13/2020
			Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Healthcare Facilities
				Instructions for Healthcare Personnel
			QLE07/24/2020
			Airway Dome
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Healthcare Facilities: Assembly and Disposal of the Airway Dome
				Instructions for Healthcare Provider (HCP): Use of the Airway Dome
			QLE09/24/2020
			COVIAGE
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Healthcare Facilities:  Assembly, Disassembly, and Disinfection of COVIAGE
				Instructions for Healthcare Personnel (HCP): Use of COVIAGE
			QLE12/18/2020
			SCONE
			(Re-issued 04/12/2021)
			Fact Sheet for Patients
				Fact Sheet for Healthcare Providers
				Instructions for Healthcare Providers and Facilities
			QLE03/29/2021
			AerosolVE Device
			(Revised Labeling 06/11/2021)
			Fact Sheet for Patients
				Fact Sheet for Healthcare Providers
				Instructions for Use
			QLE04/01/2021
			Individual Biocontainment Unit (IBU)
			(Revised Labeling 09/08/2021)
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Healthcare Providers
				Instructions for Healthcare Facilities
			QLE04/13/2020
			Airborne Isolation Hood Device
			Fact Sheet for Healthcare Personnel
				Fact Sheet for Patients
				Instructions for Use for Healthcare Facilities
				Instructions for Use for Healthcare Personnel
			QLE05/06/2021
			Negative Pressure SteriDome (NPS)
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Use
			QLE

Withdrawal Due to Other Reasons

The personal protective equipment on this list have been withdrawn at the request of the EUA holder and thus are no longer authorized and have accordingly been removed from the list of authorized EUAs above.

Date EUA Issued
			Date of Withdrawal
			PPE (Letter of Authorization)
			Other Documents
			Procode Assigned05/19/2020
			12/19/2022
			COVID-19 Airway Management Isolation Chamber (CAMIC)
			(Reissued 06/22/2020)
			Fact Sheet for Healthcare Providers
				Fact Sheet for Patients
				Instructions for Healthcare Facilities - Assembly, Disassembly and Disinfection of the CAMIC
				Instructions for Healthcare Personnel - Use of the CAMIC
			QLE

Additional Resources:

N95 Respirators, Surgical Masks, Face Masks, and Barrier Face Coverings
	Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19

                                                                                  Content current as of:
      01/30/2024
              
              
Regulated Product(s)
		 Medical DevicesCOVID-19 Emergency Use Authorizations for Medical Devices

          
                        Blood Purification Devices EUAs
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
          In Vitro Diagnostics EUAs
          Infusion Pump EUAs
          Personal Protective Equipment EUAs
          Remote or Wearable Patient Monitoring Devices EUAs
          Respiratory Assist Devices EUAs
          Ventilators and Ventilator Accessories EUAs
          Other Medical Device EUAs
 
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