MasksOn.org Regulatory Summary
The MasksOn.org product is available for use in compliance with the updated FDA Emergency Use Authorization (EUA) for face shields, governing non-traditional medical device suppliers during the COVID-19 pandemic. The MasksOn.org product is regulated and labeled as an Emergency Use face shield for medical purposes and available for use by clinicians only when FDA cleared or approved PPE is unavailable.
Supporting documentation:
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus first detected in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. Also see PREP Act declaration: Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020).
On the basis of this determination, the Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
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FDA Regulatory Timeline
Important to understanding the current regulatory status of the MasksOn.org face shield is the FDA regulatory background that allows such Emergency Use products to be manufactured and distributed to clinicians during the COVID-19 pandemic.
Frequent updates on FDA activities and decisions surrounding COVID-19, along with regulatory explanations and links to newly issued FDA regulatory documents, are posted online at Latest COVID-19 Information From the FDA.
Several postings from this FDA website page are discussed within the timeline below, with highlights added by MasksOn.org to emphasize applicability to our devices.
27 January 2020
The first post on the above page of the FDA website (FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures) includes the following statements:
“As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.”
“As part of FDA’s ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests.”
These statements indicated the early FDA interest in bringing new devices to the US market quickly, such as those developed by MasksOn.org that could potentially mitigate the spread of COVID-19.
18 March 2020
Dr. Jackie Boehme and Dr. Alex Stone reached out to Eugene Mann at Google to see if there might be an engineer or two who could help them convert recreational snorkel masks into PPE to address the looming shortage. This idea grew to eventually become MasksOn.org.22 March 2020
This FDA update included the following statement and link, indicating that FDA had not yet decided on appropriate approaches for Emergency Use PPE and that clinicians should therefore follow CDC guidelines for face and body protection:
“If No Surgical Masks and/or Gowns Are Available, see CDC’s Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids”
These CDC guidelines included general direction to clinicians to avoid airborne transmission from respiratory droplets:
“Contact transmission is generally the most common and direct contact occurs when microorganisms transfer directly from one person to another. Airborne transmission occurs by dissemination of either airborne droplet nuclei or small particles in the respirable size range containing infectious agents. Droplet transmission refers to respiratory droplets generated through coughing, sneezing, or talking. By using appropriate protective clothing, it is possible to create a barrier to eliminate or reduce contact and droplet exposure, and therefore prevent the transfer of microorganisms between patients and healthcare workers.”
However, the CDC guidelines were focused on protective clothing and did not contain specific recommendations for face coverings such as face masks or face shields. Therefore, specific guidance was still lacking regarding how clinicians could protect their inhalation of airborne COVID-19 droplets, due to the lack of face covering PPE.
26 March 2020
This important update included the publication of the FDA guidance document Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency which MasksOn.org then referenced for product labeling and distribution.
This FDA guidance document encouraged non-traditional suppliers of medical devices such as MasksOn.org to develop and distribute various PPE products for facial protection, but the guidance lacked additional details that would have helped such organizations clearly understand the appropriate pathway to follow. The initial approach of MasksOn.org (not even formally incorporated as of yet) was to follow section V. C. of that FDA guidance document (Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection), which contained the following limitations for the MasksOn.org product labeling:
“…recommendations against: use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high…”
For MasksOn.org, following the “face mask” portion of the above guidance from FDA was a logical approach at the time, given that snorkel “masks” were being modified and distributed as medical devices subject to the FDA guidance document. Therefore, initial MasksOn.org products were distributed as “face masks” and contained the above recommendations against certain clinical uses. However, in the spirit of protecting frontline healthcare workers, this conservative labeling approach allowed MasksOn.org to bring much-needed PPE to clinicians as soon as possible.
28 March 2020
This FDA update included the following statement from FDA Commissioner Stephen M. Hahn, M.D.: “As a doctor, the situation with personal protective equipment (PPE) is very concerning. We are taking every possible action we can, but we know the situation is dire for many health care facilities. We want to share that the FDA, along with the private sector, FEMA and all of the U.S. Government, are working around the clock to address this issue as quickly as possible.”3 April 2020
Addressing the dire shortage of PPE recognized by FDA, the first major shipment of snorkel masks arrived at MasksOn.org production facilities, while the development of MasksOn.org filter adapters continued.
9 April 2020
On this date, FDA issued an initial Emergency Use Authorization (EUA) regarding the production and distribution of much-needed face shields to protect clinicians during COVID-19. This was done in response to concerns relating to insufficient supply and availability of face shields for use by health care personnel (HCP) as personal protective equipment (PPE) in healthcare settings in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection during the pandemic.
This document was very detailed and focused regarding FDA requirements for face shields for medical purposes – much more so than the previously issued FDA guidance from 26 March 2020, which covered face masks for medical and non-medical purposes, face shields and respirators.
13 April 2020
On this date, FDA issued an Updated Face Shield EUA, which contained the following explanation:
“On April 13, 2020, in response to questions from stakeholders regarding the authorization process, and having concluded that revising the April 9, 2020, EUA is appropriate to protect the public health or safety under section 564(g)(2)(c) of the Act (21 U.S.C. 360bbb-3(g)(2)(c)), FDA is reissuing the April 9, 2020, letter in its entirety with an amendment incorporated to clarify that this letter of authorization, as posted and publicly announced on FDA’s website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-useauthorizations#covid19ppe, serves as face shield manufacturers’ notification of authorization.”
This updated EUA clarified that face shield suppliers such as MasksOn.org could distribute face shields without a separate EUA from FDA, as long as all aspects of the updated face shield EUA are being followed. Also important is the definition of face shield that FDA included in the EUA, presented here in its entirety:
“A face shield is a device used to protect the user’s eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. Generally, a face shield is situated at the crown of the head and is constructed with plastic to cover the user’s eyes and face. Face shields can be intended for medical or nonmedical (e.g., industrial) purposes. Face shields intended for a medical purpose are regulated by FDA under 21 CFR 878.4040 – Surgical apparel. These devices are classified as class I (general controls) and are exempt from the premarket notification requirements in 21 CFR Part 807 (“510(k) clearance”). FDA is issuing this EUA in light of availability concerns to help increase the availability of currently marketed and new face shields for medical purposes during the COVID-19 pandemic. Such face shields may provide “minimal or low barrier protection,” meaning Level 1 or Level 2 protection or equivalent under the FDA-recognized standard ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.”
24 April 2020
On this date, FDA issued a Face Mask EUA, which contained a lengthy definition of non-surgical face mask, of which an excerpt is provided here:
“A face mask is a device, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. It includes cloth face coverings as a subset. It may be for single or multiple uses, and if for multiple uses it may be laundered or cleaned.”
FDA made clear that the Face Mask EUA did not cover surgical face masks, used in more high-risk surgical settings.
On this same day, MasksOn.org reached out to internationally recognized FDA regulatory experts, to request pro bono assistance in ensuring FDA compliance of MasksOn.org activities and products, including face mask vs. face shield FDA regulatory status.
27 April 2020
Our newly engaged pro bono FDA regulatory consulting partner contacted FDA, to begin discussions on several forward-looking topics, including how MasksOn.org could add specific airborne particulate filtering claims to our product labeling, as requested by various clinicians using our devices.29 April 2020
Our FDA regulatory partner provided recommended labeling changes to the MasksOn.org products, consistent with the FDA definition of face shield (which better matches the MasksOn.org product design, functionality and medical intended use) and in compliance with the FDA Face Shield EUA requirements.
These MasksOn.org labeling changes included:
- the removal of restrictions for surgical and high liquid exposure uses (which are applicable to non-surgical face masks but not applicable to face shields)
- a descriptive change from “face mask” to “face shield”
- a descriptive change from “Experimental” to “Emergency Use” medical device
As part of the labeling review, all recommended labeling changes were approved by both MasksOn.org pro bono corporate and regulatory attorneys.
30 April 2020
The digital version of the modified MasksOn.org product labeling (User Guide) was posted on the MasksOn.org website, with all product descriptions oriented toward “Emergency Use face shield” in compliance with the FDA Face Shield Letter of Emergency Use Authorization (EUA).
27 May 2020
MasksOn.org FDA regulatory partner responds to FDA request for additional information regarding MaskOn.org interest in exploring additional claims and product definition with the FDA (beyond MasksOn.org existing compliance with FDA Face Shield Letter of Emergency Use Authorization).
03 June 2020
FDA responds to MasksOn through regulatory partner expressing an interest in working with MasksOn.org on an “interactive review” and assigns unique submission number PEAU201268.
