Surgical Masks EUA Template

Surgical Masks EUA
Template for Addition to Appendix A
This template includes the data/information requirements needed by FDA to support
addition of a surgical mask to the list of authorized surgical masks in Appendix A under
the Surgical Masks EUA (the “Surgical Masks EUA” or “EUA”), as set forth in the EUA.
As explained in the EUA, once completed, please send this interactive review template
with the subject line “Surgical Masks Eligible for EUA” to CDRH-nondiagnosticEUAtemplates@fda.hhs.gov.
GENERAL INFORMATION ABOUT THIS TEMPLATE
•

In order to be added to Appendix A, consistent with the criteria and requirements in
Section II of the EUA, text highlighted in yellow [text] must be provided to FDA as
applicable to each model number.

•

This is a template for addition to Appendix A of the Surgical Mask EUA and is not a
guidance document. It contains no new information.

•

Any trade secret or confidential commercial information provided within the template
and during the interactive review process will remain confidential.

•

Please remember that if your product is added to this specific EUA, the authorization
would only be for the use specified in the EUA and subject to the conditions in the
EUA. This device must not be introduced into interstate commerce for uses outside
the authorized use without obtaining marketing clearance, approval, IDE, or another
EUA by the FDA.

•

The Surgical Mask EUA is only in effect until the declaration that circumstances exist
justifying this authorization is terminated under Section 564(b)(2) of the Federal
Food, Drug, and Cosmetic Act (the Act) or the EUA is revoked under Section 564(g)
of the Act.

•

The EUA is not a pathway to permanent marketing of your product. For
information on premarket submissions, refer to FDA’s website on “How to Study and
Market Your Device” at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/how-study-and-market-your-device. For
information on FDA’s enforcement policy for surgical masks, see FDA guidance
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease
(COVID-19) Public Health Emergency (Revised). For guidance on modifications that
trigger the requirement that a manufacturer submit a new premarket notification
(510(k)) to FDA, refer to FDA guidance Deciding When to Submit a 510(k) for a
Change to an Existing Device.

Template for Addition to Appendix A of the Surgical Masks EUA

Template for Addition to Appendix A of the Surgical Mask EUA
A. Required Information from Section II of the EUA:
1) Applicant
Applicant information:
• Applicant Company Name:
• Applicant Address:
• Applicant Contact Person:
• Applicant Contact Phone#:
• Applicant Contact Email:
Correspondent information (if different from the Applicant):
• Correspondent Company Name:
• Correspondent Address:
• Correspondent Contact Person:
• Correspondent Contact Phone#:
• Correspondent Contact Email:
2) Device proprietary or brand name, model number:
Proprietary Name - [product trade name]
Established Name - [generic name]
Model number - [model number]
3) Product Labeling
[Provide a copy of the product labeling, including the instructions for use.]
As stated in the EUA, the product labeling must:
•
•

•

•

Describe the product as a disposable, single-use surgical mask. The labeling
must include a list of the body contacting materials (which does not include
any drugs, biologics, nanoparticles, or antimicrobial/antiviral agents);
State that the product is not intended to replace the need for FDA-cleared
surgical masks or FDA-cleared or authorized respirators;
State that surgical masks are not intended to provide protection against
pathogenic biological airborne particulates and are not recommended for use
in aerosol generating procedures and any clinical conditions where there is
significant risk of infection through inhalation exposure;
Not include statements that would misrepresent the product or create an undue
risk in light of the public health emergency. For example, the labeling must
not include any express or implied claims for: (1) reuse, (2) antimicrobial or

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Template for Addition to Appendix A of the Surgical Masks EUA

antiviral protection or related uses, (3) infection prevention, infection
reduction, or related uses, or (4) viral filtration efficiency.
4) Device Marketing Estimate
[Provide an estimate of the number of surgical masks you are planning to market
and distribute during the public health emergency.]
5) Evidence Demonstrating The Surgical Mask Meets The Criteria
[Provide a summary of the evidence demonstrating that the surgical mask
meets the criteria required in the EUA, including test reports.]
As set forth in the EUA, a surgical mask is authorized if it has been designed,
evaluated, and validated consistent with the following performance criteria and
is not excluded from the scope of authorization. The following surgical masks
are excluded from the scope and are not authorized under this EUA: (1)
surgical masks that are FDA-cleared; (2) surgical masks that are manufactured
in China; and (3) surgical masks that include drugs, biologics, nanoparticles, or
antimicrobial/antiviral agents.
a. Fluid Resistance Requirements
[Provide test reports to demonstrate that the model meets fluid resistance
requirements (liquid barrier performance) consistent with ASTM F1862: Standard
Test Method for Resistance of Medical Face Masks to Penetration by Synthetic
Blood (Horizontal Projection of Fixed Volume at a Known Velocity).]
b. Flammability Testing
[Provide test reports to demonstrate that the textiles used in the surgical mask
meet flammability performance consistent with the definition of either a Class
1 or Class 2 textile in 16 CFR Part 1610]
c. Particle Filtration Testing
[Provide test

reports to demonstrate that the model meets particulate filtration
efficiency requirements consistent with ASTM F2100: Standard Specification for
Performance of Materials Used in Medical Face Masks.]
d. Air Flow Resistance (i.e., Breathability) Assessment
[Provide evidence, including test reports, to demonstrate that the model meets air
flow resistance (i.e., breathability) requirements with an acceptance criterion of
<6 mm H2O/cm2 for differential pressure (delta P) testing consistent with ASTM
F2100: Standard Specification for Performance of Materials Used in Medical
Face Masks for those masks composed of 4 or more layers.]
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Template for Addition to Appendix A of the Surgical Masks EUA

e.

Biocompatibility Assessment

[Provide evidence, including test reports, indicating how the model has materials
of manufacture that are either (1) non-cytotoxic, non-irritating and non-sensitizing
consistent with the recommendations in FDA’s guidance, “Use of International
Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process’” or (2) conform to the
following biocompatibility standards:
• ISO 10993-1: Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests
for in vitro cytotoxicity
• ISO 10993-10: Biological evaluation of medical devices - Part 10:
Tests for irritation and skin sensitization.]
6) Authorized Distributors and/or Authorized Importers
[Please provide a list of authorized distributors and/or authorized importers,
including contact information (name, address, contact person, phone number, and
email).]
B. FDA Summary of Documentation and Review [for FDA Internal Use Only]
FDA reviewers will include a brief summary of the documentation provided and their
conclusion of whether the product meets the criteria identified in Section II.
FDA reviewers should clearly distinguish their comments and edits in the document from
the information provided by the sponsor.
C. Review Log [for FDA Internal Use Only]
Use the table below to document interactions between FDA or the sponsor.
Date
[X]

Type of Interaction
(phone/ email/ formal
submission-DCC)
[X]

Brief Description (e.g., questions asked/ feedback from
FDA received / any word documents included)
[X]

D. Next Steps
Once FDA review is completed, if the eligible product has been confirmed to meet the
criteria of the EUA, then you will receive an email notification with that information and
your product will be added to Appendix A of the Surgical Mask EUA. If the product is

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Template for Addition to Appendix A of the Surgical Masks EUA

not eligible for addition to or fails to meet the criteria of the EUA, then you will receive
an email notification with that information. Please note that, as set forth in FDA’s
guidance Emergency Use Authorization of Medical Products and Related Authorities,
FDA intends to prioritize its review of EUA requests during a declared emergency based
on various factors, including the extent to which the product would serve a significant
unmet medical need.
E. Finalizing Review [for FDA Internal Use Only]
Once FDA review is completed, FDA reviewers should finalize the documentation, sign
and date this template, and document concurrence from the OHT management.

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