FDA Requirements for Surgical and Non-Surgical Face Masks

In the United States, face masks are regulated by the Food and Drug Administration (FDA) based on their intended use.
This article outlines the regulatory requirements for both surgical and non-surgical face masks.

Surgical Masks

Definition:
Surgical masks are intended for use by healthcare professionals during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Regulatory Classification:

• Class II medical devices.
• Subject to premarket notification [510(k)] requirements.

Key Requirements:

• 510(k) Submission:
  Manufacturers must submit a 510(k) premarket notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.
• Performance Testing:
  Surgical masks should meet specific performance standards, including:
  • Fluid resistance (ASTM F1862)
  • Bacterial filtration efficiency (ASTM F2101)
  • Particulate filtration efficiency (ASTM F2299)
  • Differential pressure (Delta P) for breathability
  • Flammability (16 CFR Part 1610)
• Labeling:
  Must accurately describe the device, its intended use, and include directions for use.

Emergency Use Authorization (EUA):
During public health emergencies, such as the COVID-19 pandemic, the FDA may issue EUAs to allow the use of unapproved medical devices or unapproved uses of approved medical devices.
For surgical masks, the FDA issued an umbrella EUA to facilitate availability during shortages.
However, as of March 6, 2023, the FDA no longer adds surgical masks to the EUA’s Appendix A, and manufacturers are encouraged to pursue traditional regulatory pathways.
(FDA EUA Source)

Non-Surgical Face Masks

Definition:
Non-surgical face masks, including cloth face coverings, are intended for use by the general public to cover their nose and mouth as a source control to help prevent the spread of respiratory droplets.

Regulatory Classification:

• Generally classified as Class I medical devices.
• Exempt from 510(k) premarket notification requirements, provided they are not intended for a medical purpose.

Key Considerations:

• Intended Use:
  If the mask is intended for a medical purpose, such as infection prevention, it may be subject to FDA regulation.
• Labeling:
  Should not include claims that the mask provides antimicrobial or antiviral protection, filtration, or infection prevention unless supported by valid scientific evidence and appropriate regulatory clearance.
• Emergency Use Authorization (EUA):
  The FDA issued EUAs for non-surgical face masks during the COVID-19 public health emergency.
  These EUAs are specific to the emergency context and do not replace standard regulatory requirements.
  (FDA Non-Surgical Face Masks EUA)

Conclusion

Compliance with FDA regulations is essential for manufacturers and distributors of face masks in the U.S. market.
Understanding the distinctions between surgical and non-surgical masks, their intended uses, and associated regulatory requirements ensures that products meet safety and efficacy standards.
Manufacturers should consult the FDA’s guidance documents and consider engaging with regulatory experts to navigate the approval process effectively.