The US Food and Drug Administration (FDA) has issued an umbrella emergency use authorization (EUA) that sanctions the use of certain surgical masks in healthcare settings. The EUA was issued in response to concerns over the lack of disposable single-use surgical masks for healthcare professionals during the COVID-19 pandemic.
The EUA contains labeling and performance requirements to reduce the risk of unauthorized surgical masks being used.
Key labelling requirements include:
- Description of 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 considering 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
These products must also be accompanied by a fact sheet when being used by a healthcare professional.
Specific performance requirements 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
- Materials of manufacture must conform to either of these requirements:
- 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’”
- 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
Not included under the scope of the EUA are surgical masks that are:
- FDA-cleared
- Manufactured in China
- Include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents
EUA can be issued by the FDA during a public health emergency. This EUA was issued on August 5, 2020. To learn more about it, read the original SafeGuard 123/20.
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