By: Suzan Onel, Cynthia L. Meyer, and Justine E. Lenehan
See our later Insight published July 6, 2021, related to FDA’s revocation of certain EUAs and guidance documents discussed below.
Published June 18, 2020; Updated August 9, 2020
In its ongoing efforts to expand the availability of general use face masks for the general public and filtering facepiece respirators (including N95 respirators) (“FFRs”) for healthcare personnel (“HCP”) during the COVID-19 public health emergency, FDA has updated its guidance document entitled “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” (the “Enforcement Policy”). The current version supersedes an earlier version issued in April 2020 (which similarly superseded the original March 2020 Guidance).
The principal changes in FDA’s Enforcement Policy include: (1) updates regarding alternatives when FDA-cleared or National Institute for Occupational Safety and Health (“NIOSH”)-approved N95 respirators are not available and (2) striking FDA’s recommendations regarding Emergency Use Authorizations (EUAs) for decontamination of face masks and FFRs.[1] The Enforcement Policy does not change the “umbrella” EUA FDA issued on April 24, 2020, for certain face masks intended as source control to help prevent the spread of the SARS-CoV-2 during the COVID-19 pandemic. FDA’s April 24, 2020, “umbrella” EUA can be found here.
This Enforcement Policy and the related EUAs remain in effect only for the duration of the public health emergency related to COVID-19.
SCOPE
FDA’s Enforcement Policy applies to certain face masks, face shields, surgical masks, and respirators that are intended for a medical purpose (i.e., intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease) and thus are regulated by FDA as medical devices. It includes, for example, surgical masks (with or without antimicrobial/antiviral agents), pediatric/child facemasks, face shields, and N95 respirators, but does not include other FDA-regulated masks such as respiratory gas humidifiers, oxygen masks, noncontinuous ventilators, or gas masks.
Products intended for a non-medical purpose (e.g., intended to be used in construction or other industrial applications) are not medical devices and therefore not subject to FDA regulation. In order to determine whether face masks, face shields, and respirators are intended for a medical purpose, FDA will consider whether:
- They are labeled or otherwise intended for use by an HCP;
- They are labeled or otherwise intended for use in a health care facility or environment; and
- They include any drugs, biologics, or anti-microbial/anti-viral agents.
EUAS FOR FACE MASKS AND FFRS
FDA has separately issued a series of EUAs pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. § 360bbb-3(b)(1)(C)), to respond to continuing concerns about the availability face masks and FFRs (most notably respirators).[2] The EUAs allow for the distribution and use of certain devices during the duration of the pandemic without compliance with specified FDA requirements if they meet the enumerated eligibility criteria and conditions of authorization. Notably, the conditions for authorization include certain labeling requirements, disclosures, notification to end users/facilities, adverse event reporting, inventory control, and record keeping, among other items.
For those manufacturers of masks and respirators that are not currently legally marketed in the United States and fall outside of an existing EUA, FDA has stated that it is interested in interacting with them on additional device-specific EUAs. FDA’s Enforcement Policy includes an outline of suggested information to compile to facilitate this discussion.
1. Face Masks Intended for a Medical Purpose
Non-surgical face masks intended to protect the patient and hospital staff from the transfer of microorganisms, body fluids, and particulate material are regulated as medical devices under section 201(h) of the FDCA and 21 C.F.R. § 878.4040. They are generally Class I devices that do not require a premarket submission, but are subject to device general controls that include establishment registration and device listing, compliance with the Quality System Regulation (unless specifically exempted), adverse event reporting, and compliance with other general device requirements.
Due to shortages caused by the COVID-19 public health emergency and based on an assessment of the potential benefits and risks, FDA concluded that it was appropriate to issue a general EUA for face masks, including cloth face coverings, that are intended for use only as source control to help prevent the spread of the SARS-CoV-2 during the pandemic. Under the FDA’s April 24, 2020, “umbrella” face mask EUA, these devices may be distributed subject to the EUA’s eligibility requirements and compliance with the listed Conditions of Authorization. The “umbrella” EUA does not apply to face masks intended to be used by HCPs as personal protective equipment (“PPE”) (i.e., respiratory protective devices, such as FFRs) or surgical masks.
2. FFRs and Respirators Intended for a Medical Purpose
FFRs, such as N95 Respirators, intended to be used as PPE are regulated as medical devices under the same statutory and regulatory provision as non-surgical face masks, but, depending on the intended use, require either FDA clearance of a 510(k) premarket notification or are exempt from the 510(k) requirement if they conform with specified conditions which include NIOSH-approval.
In order to respond to shortages caused by the COVID-19 public health emergency and support the CDC’s recommendations for optimizing the supply of N95 respirators, FDA issued three EUAs to provide flexibility regarding distribution and use of alternatives to FDA-cleared or NIOSH-approved N95 respirators and FFRs in healthcare settings by HCPs: NIOSH-approved FFRs, imported non-NIOSH-approved disposable FFRs from certain jurisdictions excluding China, and non-NIOSH-approved disposable FFRs manufactured in China. FDA continues to update these EUAs as the Agency learns new information. For instance, FDA revised its EUA on FFRs manufactured in China first to remove numerous respirators that FDA learned were the subject of subpar performance testing, and more recently to advise that no products remaining under the scope of the China EUA are eligible for reuse after decontamination. Like the face mask “umbrella” EUA, FFRs and respirators subject to one of these EUAs must meet the EUA’s eligibility requirements and comply with the listed Conditions of Authorization.
FDA ENFORCEMENT POLICY
FDA’s previous Enforcement Policy stated that it does not intend to object to distribution and use of certain respirators even if they were not FDA-cleared, NIOSH-approved, or authorized under an EUA. However, since that time, FDA became aware of concerns regarding the performance of certain respirators. Consequently, under the current Enforcement Policy, FDA announced that it is discontinuing this policy and recommends the use of FDA-cleared or NIOSH-approved N95 respirators when available or, when those are unavailable, the use of respirators authorized under an EUA. FDA does not recommend the use of a product as a respirator if it does not meet one of these criteria; however, such a product could be used as a face mask by the general public or HCPs as source control if labeled correctly and the criteria are met under the “umbrella” EUA for non-surgical face masks.
The Enforcement Policy also articulates FDA’s current policy for certain other categories of face masks, generally consistent with its prior guidance:
| Criteria to Qualify Under FDA’s Enforcement Policy | Regulatory Requirements FDA Does Not Intend to Enforce Under its Enforcement Policy | |
|---|---|---|
| Face Masks for Source Control Not Intended to Provide Liquid Barrier Protection | • The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFR) and includes a list of the body-contacting materials (which may not include any drugs or biologics); • The product includes labeling that makes recommendations that would reduce sufficiently the risk of use (e.g., recommendations against use in any surgical setting or where significant exposure to liquids, bodily or other hazardous fluids may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas); and • The product is not intended for any use that would create an undue risk in light of the public health emergency (e.g., the labeling does not include uses for antimicrobial or antiviral protection (or related uses) or uses for infection prevention or reduction (or related uses) and does not include particulate filtration claims). Note that FDA includes additional criteria under the April 24, 2020, “umbrella” EUA. | • 510(k) Premarket Notification requirement in 21 C.F.R. § 807.81; • Registration and Listing requirements in 21 C.F.R. Part 807; • Quality System Regulation requirements in 21 C.F.R. Part 820; • Reports of Corrections and Removals in 21 C.F.R. Part 806; and • Unique Device Identification requirements in 21 C.F.R. Part 830 and 21 C.F.R. § 801.20. |
| Face Shields | • The product includes labeling that accurately describes the product as a face shield and includes a list of the body-contacting materials (which may not include any drugs or biologics); • The face shield does not contain any materials that will cause flammability, or the product meets the Class I or Class II flammability requirement per 16 C.F.R. Part 1610 (unless labeled with a recommendation against use in the presence of a high intensity heat source or flammable gas); and • The product is not intended for any use that would create an undue risk in light of the public health emergency (e.g., the labeling does not include uses for antimicrobial or antiviral protection (or related uses) or uses for infection prevention or reduction (or related uses), or for radiation protection). | • Registration and Listing requirements in 21 C.F.R. Part 807; • Quality System Regulation requirements in 21 C.F.R. Part 820; • Reports of Corrections and Removals in 21 C.F.R. Part 806; and • Unique Device Identification requirements in 21 C.F.R. Part 830 and 21 C.F.R. § 801.20. |
| Surgical Masks Intended to Provide Liquid Barrier Protection | • The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862; • The product meets the Class I or Class II flammability requirement per 16 C.F.R. Part 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas); • The product includes labeling that accurately describes the product as a surgical mask and includes a list of the body-contacting materials (which may not include any drugs or biologics); • The product is not intended for any use that would create an undue risk in light of the public health emergency (e.g., the labeling does not include uses for antimicrobial or antiviral protection (or related uses) or uses for infection prevention or reduction (or related uses) and does not include particulate filtration claims). Note that FDA includes additional criteria under the August 5, 2020, “umbrella” EUA. | • 510(k) Premarket Notification requirement in 21 C.F.R. § 807.81; • Registration and Listing requirements in 21 C.F.R. Part 807; • Quality System Regulation requirements in 21 C.F.R. Part 820; • Reports of Corrections and Removals in 21 C.F.R. Part 806; and • Unique Device Identification requirements in 21 C.F.R. Part 830 and 21 C.F.R. § 801.20. |
FDA’s full list of COVID-19-related guidance documents may be found here. FDA has also made available a Frequently Asked Questions page on the “umbrella” EUA for non-surgical face masks, as well as a webpage addressing questions related to manufacturing, purchasing, importing, and donating face masks and FFRs during COVID-19. We will continue to monitor Agency guidance on this topic. Please contact us if you have any questions or would like to discuss further.
[1] This latter topic is now addressed separately in a new guidance document entitled “Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
[2] Since publication of this alert in June, FDA also issued an “umbrella” EUA on August 5, 2020, for certain disposable, single-use surgical masks. Such EUA can be found here.