EUA for disposable, single-use surgical masks
On August 5, 2020, FDA issued an umbrella EUA ("the EUA") for the use of disposable, single-use surgical masks intended to provide a physical barrier to fluids and particulate materials to prevent health care personnel exposure to respiratory droplets and large particles. It is important to note that the EUA applies to surgical masks – not to general use facemasks that are not intended for use in a surgical setting. Facemasks not intended to provide liquid barrier protection or not intended for use in a surgical setting are covered in separate EUAs and guidance policies. The scope of the EUA also does not apply to filtering face piece respirators (e.g., N95, KN95, etc.) as those types of PPE are covered by other EUAs. The EUA also does not cover surgical masks that include or are coated with drugs, biologics, nanoparticles, or antimicrobial/antiviral agents. The EUA also excludes from its scope any surgical masks that are manufactured in China.
The Letter of Authorization states that surgical masks that have been designed, evaluated, and validated in accordance with the specific performance criteria described in the EUA Letter of Authorization. Specifically, those criteria are:
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; and
The materials of manufacture are either (1) non-cytotoxic, non-irritating and non-sensitizing consistent with the recommendations in 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’” or (2) conform to the 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; and
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Companies are required to provide test reports and demonstrate that the surgical masks meet the performance criteria specified in the EUA.
Impact on industry going forward
This new umbrella EUA does not impact other EUAs or enforcement discretion issued by the agency for non-surgical facemasks or filtering face piece respirators. This EUA significantly reduces the burdens for the entry of new surgical masks to the medical community in the U.S. Companies should closely follow the requirements outlined in this EUA policy for surgical masks, labeling requirements, and follow-up with the agency.
The agency’s exclusion of surgical masks manufactured in China represents a similar approach taken earlier this year when Chinese made respirators were excluded from the scope of EUAs issued by the agency. FDA ultimately changed its policies and issued an EUA specific to respirators manufactured in China on April 3. That EUA was significantly modified on May 7 and EUA some 50 plus authorized Chinese respirators removed from FDA’s list after testing performed by the National Institute of Occupational Safety and Health (NIOSH) identified failures to meet particulate efficiency standards. It is unclear whether FDA is working on or intends to issue a different policy that would apply to Chinese made surgical masks as it ultimately did with KN-95 respirators. (See also, our client alert on President Trump’s "Buy America" Executive Order).
It should be noted that each of the EUAs and enforcement discretion policies only apply until the circumstances created by the COVID-19 public health emergency no longer exist. Should companies wish to continue marketing these products after the emergency circumstances have subsided, absent the issuance of a disposition policy or program, the standard FDA regulatory requirements would apply.
We will continue to monitor FDA’s response to COVID-19. Please contact us if you have any questions.
Authored by Michael Heyl and Seth Olson