March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
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: Recent Final Medical Device Guidance Documents.
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
For information on EUAs that were previously issued but no longer in effect, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.
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 A
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 ECO05|
|10/29/2021||MOCACARE Corporation||MOCACARE Surgical Mask (Level 3)
Model number: BC1005
|07/12/2021||SurgiMac Manufacturing Inc.||Surgical Mask (Model – MAC-6501)|
|06/30/2021||Thrace Polyfilms S.A.||Surgical Masks Model PLF.IIR|
3 Ply Surgical Mask (Model # 62212)
|05/07/2021||Health Pro Supplies Limited||
Medical Surgical Mask HP2723 (Large)
Medical Surgical Mask HP9503
|08/08/2020||Outdoor Research||Outdoor Research Surgical Mask model #OR2159|
|08/18/2020||Venus Group, Inc.||Venus Medical Grade Disposable Surgical Mask|
|10/05/2020||Hanesbrands, Inc.||Hanes Surgical Mask 01, Small and Large|
|10/08/2020||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-LARGE|
|11/03/2020||Fischer Manufacturing, LLC||Heartland Health Surgical Mask|
Surgical Mask - Disposable Single-Use 4-Ply Earloop
Surgical Mask - Disposable Single-Use 4-Ply Tie-on
Surgical Mask (Tie-On)
Surgical Mask (Earloop)
|12/09/2020||Nomad Goods||Nomad Surgical Mask N-MASK-3|
|12/10/2020||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
|12/10/2020||MOCACARE Corporation||MOCACARE Procedure Mask (Level 1)
Model #: BC1003
|12/16/2020||Honeywell International Inc.||Procedure Mask with Earloops
Model #: 559250M
|12/19/2020||Honeywell International Inc.||Procedure Mask with Earloops
Model #: 559250M B and 559250M C
|01/22/2021||Honeywell International Inc.||Procedure Mask with Earloops
Model #: 559250M D
|01/19/2021||KNH Enterprise Co., Ltd.||
KNH Surgical Face Mask
|01/29/2021||131co Inc.||ARX Surgical Mask (Model number ARX1001)|
|02/12/2021||SIO International Wisconsin, Inc||Sharp MQ-3050 Surgical mask; Foxconn MQ-3050 Surgical mask|
|03/19/2021||Cleveland Veteran Business Solutions||CVBS Surgical Mask - Model Number: SM1|
|03/29/2021||Protektair, Inc||Protektair-3 Surgical Mask Model #: PSM-3000|
|03/30/2021||PZero Innovations, Inc.||PZero Surgical Mask Model Number: FM20PZ00|
|04/06/2021||Keeo Life Private Limited||3PLY Surgical Mask KF-SM3-EL
4PLY Surgical Mask KF-SM4-EL
|04/19/2021||BLUETRACK, Inc.||Healthcare Pro Surgical Masks
|04/16/2021||Manohar Filaments Private Limited||3 Ply Surgical Mask
|04/21/2021||GRAFICA VENETA S.p.A.||MASK MEDICA GV 2 GV2-GVII-202007|
|04/28/2021||Devshree International Pvt. Ltd.||Hoplon Brand Disposable Single Use Surgical Masks Level 1 per ASTM F2100 H3SS|
|04/29/2021||Phoenix Quality MFG, LLC||PQM LibertyAir Surgical MaskModel - S-9501-EUA|
|04/29/2021||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-S201B|
|05/21/2021||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 - LM1019
|10/28/2021||DediCare Medical Solution LLC||Surgical Mask, Model Number – SM3101|
|11/05/2021||Mahe Medical Service GmbH||Mahe Medical Disposable Surgical Face Mask with Earloops, Model 001-USA-E|
|01/12/2022||Sidra Medical Supply Inc.||Sidra Surgical Face Mask AD3PL2WH|
|01/14/2022||Little Rapids Corporation||Graham Medical® Surgical Masks – Model Numbers: 88037 & 88038|
|01/14/2022||Supermax Healthcare Canada – Supermax Medical||Surgical Mask, Model Number – 2130|
|03/04/2022||Supermax Healthcare Canada – Supermax Medical||Surgical Mask, Model Number – 2110
Surgical Mask, Model Number – 2120
|01/18/2022||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 Medical™ Procedural Masks with Ear loops||Surgical Mask, Model Number – SL3P1710|
|02/07/2023||Medplan Private Limited||MED-2002-EL (50 pieces/box)|
|02/09/2023||MDT Medical Products||MDT Medical Products 3PLY Mask|
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.
|Manufacturer||Surgical Mask Model(s) No Longer Authorized|
|01/21/2021||Premier Guard USA LLC||Premier Guard USA Surgical Face Mask 20-1002-SFM3|
Surgical Mask - Disposable Single-Use 3-Ply Earloop
Surgical Mask - Disposable Single-Use 3-Ply Tie-on
|03/19/2021||Homtex, Inc.||Sovereign America Surgical Mask
Model #: 2000SM1, Blue color
|06/15/2021||Premium-PPE Amerishield||Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S|
|07/23/2021||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
INTAI SURGICAL MASK (non-sterile) - ASTM Level3
|12/16/2021||Liberty Mask, LLC||
LM Surgical Mask Level 3
|06/14/2023||PADM Medical Inc.||PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops (black - 100195, white - 100196)|
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 Documents|
|03/28/2020||NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency|
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 Assigned|
|05/04/2021||ISOCUBE SS and ISOCUBE ONE||QLE|
|05/08/2020||Patient Isolation Transport Unit (PITU) Device||QLE|
|05/27/2020||Gowns and Other Apparel||
|06/13/2020||Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)||QLE|
(Revised Labeling 06/11/2021)
|04/01/2021||Individual Biocontainment Unit (IBU)
(Revised Labeling 09/08/2021)
|04/13/2020||Airborne Isolation Hood Device||QLE|
|05/06/2021||Negative Pressure SteriDome (NPS)||QLE|
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 Assigned|
COVID-19 Airway Management Isolation Chamber (CAMIC)