August 21, 2020
Understanding the FDA requirements to market surgical masks with an emergency use authorization (EUA) during the COVID-19 pandemic
On August 5, 2020, in response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an umbrella emergency use authorization (EUA) intended to address supply shortages of surgical masks. Surgical masks are defined as "fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment." They are for use in surgical settings and do not provide full protection from inhalation of airborne pathogens, such as viruses. As defined by FDA in the EUA letter, surgical masks are personal protective equipment (PPE) that prevent health care providers (HCPs) from being exposed to respiratory droplets and large particles.
This EUA is in addition to prior EUAs issued related to PPE, including 1) N95 and other respirators (including NIOSH-approved N95s and imported respirators), 2) non-NIOSH-approved disposable filtering facepiece respirators (FFRs) manufactured in China, 3) imported, non-NIOSH-approved disposable FFRs, and 4) face shields and other barriers.
FDA has outlined the performance criteria it intends to review as part of EUA submissions and what it expects to be included to demonstrate:
- Fluid Resistance Requirements: Liquid barrier performance testing conducted following 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 per Class 1 or 2 textile (16 CFR 1610).
- Particulate Filtration Efficiency (PFE) per ASTM F2100, Specification for Performance of Materials Used in Medical Face Masks.
- Air flow resistance (e.g., breathability) per ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks, for masks made of four or more layers.
- Biocompatibility assessment to confirm that the materials composing the surgical mask conform to ISO 10993-1, ISO 10993-5, and ISO 10993-10.
The FDA site provides a link to a template for sponsors to submit the requested information. The template identifies clearly the information FDA expects, including information to conform to the criteria set forth in section II of the EUA letter. Sections include 1) Applicant; 2) Device Name, Model Number; 3) Product Labeling; 4) Device Marketing Estimate; 5) Evidence Demonstrating that the Surgical Mask meets the Criteria Listed Above (items 1 — 5); and 6) Authorized Distributors and/or Importers.
Part of the conditions of authorization include:
- Including authorized labeling, as well as the HCP fact sheet provided by FDA.
- Complying with 21 CFR 803 for reporting adverse events.
- Maintaining appropriate records related to EUA.
- Maintaining appropriate records of distribution of the surgical masks.
- Notifying FDA of authorized distributors or importers.
- Submitting to FDA, upon request, surgical masks for testing by FDA.
FDA also outlines additional responsibilities for authorized distributors and importers, as well as conditions related to advertising and promotion. As of August 20, 2020, Appendix A for EUAs for Surgical Masks only includes two authorized manufacturers.
How Exponent Can Help
Exponent's multidisciplinary team of consultants supports clients with technical, safety, risk assessment, and regulatory issues for PPE and other medical devices. We can assist with quality system gap assessments, verification and validation testing, user study design and management, labeling generation and labeling modification, and generation of data in support of an EUA submission. Our offerings also include reviewing testing data to assess the completeness of the package for EUA submission.