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
  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.

SGS Medical PPE Services

SGS offers a full range of
services to help manufacturers and suppliers of medical PPE deliver high
quality, safe, and compliant products to markets around the world. Learn more
about SGS Medical PPE
Services.

SGS SafeGuardS keep you up to date with
the latest news and developments in the consumer goods industry. Read the full FDA Issues
New Emergency Use Authorization for Surgical Masks SafeGuardS.

Subscribe here to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Matthew
Mcgarrity
Senior
Technical Manager
Tel: +1 (973) 461 1505

Email: crs.media@sgs.com

Website: www.sgs.com/hardlines

LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection,
verification, testing and certification company. SGS is recognized as the
global benchmark for quality and integrity. With more than 89,000 employees,
SGS operates a network of over 2,600 offices and laboratories around the world.