SAFEGUARDS | Personal Protective EquipmentNO. 123/20
On August 5, 2020, the US Food and Drug Administration (FDA) issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks.
This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent healthcare personnel (HCP) exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
FDA’s Emergency Use Authorizations
During a public health emergency, the FDA can use EUA to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
Before the FDA can issue an EUA, the Secretary of Health and Human Services must make a declaration of emergency or threat justifying authorization of emergency use for a product.
When the emergency is over, the EUA declaration is terminated, and all EUAs issued based on that declaration will no longer remain in effect.
Typically, EUAs will established certain requirements intended to mitigate undue risk of unapproved or unapproved use of medical devices. Meeting applicable requirements outlined in an EUA are essential.
To help address concerns about availability during the COVID-19 pandemic, the FDA has issued EUAs for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators.
To aid in the industry understanding, the FDA has released an FAQ on EUAs for medical devices during the COVID-19 pandemic.
Requirements of FDA’s Surgical Masks EUA
As with other EUAs, to limit undue risk of the authorized surgical masks the EUA includes labeling and performance requirements, among other requirements.
Key labeling requirements include:
- 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; and
- 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 antiviral protection or related uses, (3) infection prevention, infection reduction, or related uses, or (4) viral filtration efficiency
In addition to above labeling, authorized products must be accompanied with a fact sheet when being made available to HCP:
- Fact Sheet for Healthcare Personnel: Emergency Use of Authorized Disposable, Single Use Surgical Masks During the COVID-19 Pandemic
Specific performance criteria for authorized surgical masks include:
- 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)
- Flammability performance consistent with the definition of either a Class 1 or Class 2 textile in 16 CFR Part 1610
- Particulate filtration efficiency requirements consistent with ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- 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
- The materials of manufacture are either:
- Non-cytotoxic, non-irritating and non-sensitizing consistent with the recommendations in the 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’”10 or
- 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
The FDA has provided a template that can be used for submittal to FDA. Referred as “Template A”, it 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, as set forth in the EUA. Once completed, templates can be submitted along with test reports to the above criteria for review via e-mail with the subject line “Surgical Masks Eligible for EUA” to CDRH-nondiagnosticEUAfirstname.lastname@example.org
Surgical masks that have been confirmed by the FDA to meet the criteria under the EUA are included in “Appendix A: Authorized Surgical Masks” which can be found on the FDA website.
Note, the following surgical masks are excluded from the scope and are not authorized under this EUA:
- Surgical masks that are FDA-cleared
- Surgical masks that are manufactured in China, and
- Surgical masks that include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents
SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.
Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.
SGS can assist with testing to the methods specified in this surgical mask EUA, as well as other FDA guidances and regulations.
For enquiries, please contact:
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