FDA Authorizes the Use of Certain Surgical Masks in Healthcare Settings

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
  • 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

    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
  • 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

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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