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Recent FDA Guidance on the Distribution, Use, and Importation of Disposable Filtration Masks and Face Shields

April 24, 2020

Overview

As the COVID-19 outbreak expands, supply chains have been stressed for general use face masks, surgical masks, and similar disposable devices for filtering airborne particulates, as well as medical face shields. To help expand the availability of general use face masks for the general public, and of filtering facepiece respirators (“FFRs”) like N95 respirators for healthcare professionals, the U.S. Food and Drug Administration (“FDA”) has recently issued several guidance documents easing restrictions on the distribution, use, and importation of such devices.

Regulation of Filtration Masks Generally

Any device intended to prevent disease is subject to regulation as a “medical device” by the FDA. Manufacturers of face masks intended to prevent disease must typically comply with the requirements of the Federal Food, Drug, and Cosmetic Act, such as registration and listing of devices sold (21 C.F.R. Part 807); adequate labeling of devices (21 C.F.R. Part 801), including Unique Device Identification requirements (21 C.F.R. § 801.20, 21 C.F.R. Part 830); reporting of device-related adverse events (21 C.F.R. Part 803); good manufacturing practices required by the Quality System Regulation (21 C.F.R. Part 820); reporting of corrections and removals (21 C.F.R. Part 806); and other controls. For example, FFRs for use by the general public to reduce exposure to airborne pathogens must typically be certified as N95 respirators by the National Institute for Occupational Safety and Health (“NIOSH”) (21 C.F.R. § 880.6260), and surgical masks and many N95 respirators are typically subject to Section 510(k) premarket notification requirements (21 C.F.R. § 878.4040).

Current FDA Enforcement Policy

In April 2020, the FDA issued a guidance document titled “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” superseding a prior guidance document issued March 25, 2020. In its updated guidance, the FDA clarifies several aspects of its intended approach, for the duration of the public health emergency, to regulation of these products.

Non-medical devices. The FDA explains that face masks, face shields, and N95 respirators not intended for any medical purpose, such as the prevention of disease, are not subject to FDA regulation as medical devices. The FDA states that when evaluating whether such products are intended for a medical purpose, it will consider whether (1) they are labeled or otherwise intended for use by a healthcare professional; (2) they are labeled or otherwise intended for use in a healthcare facility or environment; and (3) they include any drugs, biologics, or antimicrobial/antiviral agents. This suggests that for the duration of the COVID-19 emergency, the FDA potentially may not, in its discretion, consider a face mask or respirator to be a regulated “medical device” simply because it is used to reduce exposure to germs by the general public.

Regulation of face shields and face masks other than respirators. The FDA also states that for the duration of the public health emergency, it does not intend to object to the distribution and use of certain classes of devices without compliance with certain listed regulatory requirements, so long as the product does not create an undue risk in light of the public health emergency. The FDA’s guidance on particular categories of products is set forth in the table below. Certain of these enforcement guidelines have also been formalized in Emergency Use Authorizations (“EUAs”), as discussed further below.

Product Description

Regulatory Requirements for Which FDA Intends to Relax Enforcement

The Product Would Not Create an Undue Risk Where:


Medical face masks (not including respirators)* not intended to provide liquid barrier protection

  • Section 510(k) premarket notification
  • Registration and Listing requirements
  • Quality System Regulation requirements
  • Reports of corrections and removals
  • Unique Device Identification requirements
  • The product does not include any drugs or biologics, and has labeling including a list of body contacting materials.
  • The labeling accurately describes the product as a face mask, as opposed to a surgical mask or FFR.
  • The labeling makes recommendations to reduce the risk of use, for example, recommendations against use in a surgical or clinical setting, or other environment where significant exposure may be expected; and against use in the presence of a high-intensity heat source or flammable gas.
  • The product is not intended for any use that would create an undue risk in light of the public health emergency. For example, the labeling should not include uses for antimicrobial protection, antiviral protection, infection prevention or reduction, or related uses; and should not include particulate filtration claims.


Medical face shields

  • Registration and Listing requirements
  • Quality System Regulation requirements
  • Reports of corrections and removals
  • Unique Device Identification requirements
  • The product does not include any drugs or biologics, and has labeling including a list of body contacting materials.
  • The product either recommends against use in the presence of a high-intensity heat source or flammable gas, does not include flammable materials, or meets certain regulatory flammability requirements.
  • The product is not intended for any use that would create an undue risk in light of the public health emergency. For example, the labeling should not include uses for antimicrobial protection, antiviral protection, infection prevention or reduction, radiation protection, or related uses.


Surgical masks intended to provide liquid barrier protection

  • Section 510(k) premarket notification
  • Registration and Listing requirements
  • Quality System Regulation requirements
  • Reports of corrections and removals
  • Unique Device Identification requirements
  • The product does not include any drugs or biologics, and has labeling including a list of body contacting materials.
  • The labeling accurately describes the product as a surgical mask.
  • The product either recommends against use in the presence of a high-intensity heat source or flammable gas, or meets certain regulatory flammability requirements.
  • The product satisfies fluid resistance testing consistent with standard ASTM F1862.
  • The product is not intended for any use that would create an undue risk in light of the public health emergency. For example, the labeling should not include uses for antimicrobial protection, antiviral protection, infection prevention or reduction, or related uses; and should not include particulate filtration claims.

* In this document, the FDA defines a “face mask” as “a mask … that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels,” as distinguished from FFRs such as N95 respirators.

“N95”-type respirators approved under standards used in other countries. Additionally, the FDA states that when FDA-cleared or NIOSH-approved N95 respirators are not available, it will relax enforcement standards for certain respirators approved under standards used in other countries, which have been identified by the Centers for Disease Control (“CDC”) as comparable alternatives. A list of such alternatives is available on this CDC page under the heading, “Use of respirators approved under standards used in other countries that are similar to NIOSH-approved respirators.”

For the duration of the public health emergency, the FDA states that it does not intend to object to the importation, distribution, or use of such respirators without compliance with Section 510(k) premarket notification requirements, Registration and Listing requirements, Quality System Regulation requirements, reports of corrections and removals, or Unique Device Identification requirements. Because the FDA cannot confirm the authenticity of such respirators, it recommends that importers take appropriate steps to verify the authenticity of such imported products. 

With respect to use by healthcare personnel only, certain respirators approved under standards used in other countries are also subject to specific EUAs, as discussed below.

EUAs for face masks and respirators. The FDA stated its intent to work with manufacturers on device-specific EUAs, as well as EUAs relating to the reprocessing and decontamination of face masks and respirators, in order to expedite authorization of these products and processes outside of normal regulatory channels. The FDA invited interested stakeholders to supply listed information to CDRH-COVID19-SurgicalMasks@fda.hhs.gov to facilitate expedited approval through an EUA. Many face masks and respirators are already subject to generally applicable EUAs, as discussed below.

Emergency Use Authorizations (EUAs) Relating to Face Masks, Face Shields, and Respirators

Over the past several weeks, the FDA has issued numerous EUAs authorizing use of personal protective equipment (“PPE”) outside of normal regulatory channels, including updates to prior authorizations issued since the public health emergency was declared. While this article discusses only general EUAs for face masks, face shields, and respirators, the FDA’s full list of EUAs relating to PPE is available here.

While most of the EUAs discussed below apply only to use by healthcare personnel, distribution of the referenced products to the general public may still be subject to the current enforcement policies discussed above.

NIOSH-approved respirators. On March 28, 2020, the FDA issued an EUA authorizing the use, by healthcare personnel only, of nearly all NIOSH-approved FFRs, other non-powered respirators, and powered air purifying respirators. This includes devices approved for industrial rather than medical use, devices that have passed the manufacturers’ recommended shelf life, and devices that have been reprocessed through an authorized decontamination system. This EUA updates prior authorizations issued on March 2, 2020, and March 27, 2020. The EUA is available here, and includes details on authorized devices and conditions for authorization, such as labeling, advertising, reporting, and record retention requirements. 

Imported, non-NIOSH-approved FFRs. Also on March 28, 2020, the FDA issued an EUA making eligible for authorization, for use by healthcare personnel only, certain FFRs designed, evaluated, and validated under performance standards used in other countries. This includes FFRs approved under applicable standards in Australia, Brazil, Europe, Japan, Korea, and Mexico, as well as FFRs with specified marketing authorizations in Europe, Australia, Canada, and Japan. This EUA updates a prior authorization issued on March 24, 2020. The EUA is available here, and includes details on authorized devices and conditions for authorization, including a requirement that manufacturers and importers send certain information to the FDA before their products can be added to the list of authorized devices.

On April 3, 2020, the FDA issued a separate EUA making eligible for authorization, for use by healthcare personnel only, FFRs manufactured in China, including FFRs with regulatory authorizations in China and other jurisdictions. As with FFRs authorized under the March 28, 2020 EUA, manufacturers and importers of such respirators must send certain information to the FDA before their products can be added to the list of authorized devices, as well as comply with other conditions of authorization. The EUA is available here.

Face shields. On April 13, 2020, the FDA issued an EUA authorizing the use by healthcare personnel of stand-alone face shields not including any other article of PPE (such as a mask) that meet certain labeling and materials requirements. Manufacturers of such products need not take any action for approval, other than compliance with the labeling, instructions, advertising, records retention, and reporting requirements specified in the EUA, which are comparable to the guidelines set forth in the FDA enforcement policy discussed above. This EUA updates a prior authorization issued on April 9, 2020, and is available here.

Non-filtering face masks. On April 18, 2020, the FDA issued an EUA authorizing the use by the general public (including healthcare personnel) of face masks not intended to provide any specific degree of particulate filtration, such as cloth face coverings, that meet certain labeling requirements. Manufacturers of such products need not take any action for approval, other than compliance with the labeling, instructions, advertising, records retention, and reporting requirements specified in the EUA, which are comparable to the guidelines set forth in the FDA enforcement policy discussed above. The EUA is available here.

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