The article provides an overview of the regulatory approach to be applied with respect to certain medical devices used in the context of the pandemic. 

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the enforcement policy for face masks and barrier face coverings during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” and the public health emergency associated thereto. In particular, the document describes temporary and extraordinary measures the authority undertakes in order to ensure and expand the availability of the said devices in the context of the increased demand they may face. 

At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by the parties involved in order to ensure compliance thereto. Furthermore, the authority explicitly states the alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance. 

The present document published in March 2023 supersedes previous versions of the same guidance issued earlier by the FDA.  

Regulatory Background 

First of all, the document emphasizes the importance of the FDA’s role in creating a favorable framework for medical devices while ensuring their continued safety, proper performance, and public health protection in general. This becomes especially important in the context of the pandemic and public health emergency associated thereto. 

The regulatory policy and special measures set forth therein are intended to remain effective for 180 days following the expiration of the public health emergency announced due to the outbreak of COVID-19. With respect to the validity of COVID-related policies, the authority refers to a respective guidance document whereby the related matters are addressed. 

It is also important to mention that due to the urgency and current public needs, the policy described in the present guidance is subject to immediate implementation without prior public consultations required under the general procedure. However, the authority anyway encourages the industry representatives to provide their comments and suggestions to be considered when developing a new version of the document. 

The guidance also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers may refer to when demonstrating compliance with the applicable regulatory requirements their products are subject to. In such a way the regulatory burden could be reduced significantly. 

As it is stated by the FDA, the policy set forth in this guidance was intended to help to address the urgent public concerns by clarifying the regulatory landscape of face masks and barrier face coverings and helping to expand the availability of these devices for use by the general public and healthcare personnel (HCP) in healthcare settings, as appropriate. 

The authority further provides an overview of the most important changes made to the guidance in different revisions of the document. For instance, in revisions dated April and May 2020, as well as September 2021, new devices have been added to the scope of the guidance. 

Scope of Application 

The authority acknowledges that currently a wide range of products is available on the US market, promoted as “face masks” intended to provide protection against various health hazards. In accordance with the applicable regulatory requirements, face masks, and barrier face coverings are regulated by FDA when they meet the definition of a device under section 201(h)(1) of the FD&C Act; generally, face masks and barrier face coverings fall within this definition when they are intended for a medical purposes, including for use by HCP. Consequently, products that are not intended for a medical purpose, are falling outside the scope of the medical devices framework. 

In order to assist the parties involved in determining the regulatory nature of the products they are responsible for, the authority provides tables outlining the products covered by the scope of the guidance and falling outside its scope respectively. 


Terms and Definitions 

The authority also provides definitions of the most important terms and concepts used in the context of the guidance document and policy described therein. According to the guidance, the key terms should be interpreted as follows:

  • Face Mask – a mask, 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. The authority mentions that face masks could be used by both healthcare professionals and general public. 
  • Barrier Face Covering – as described in ASTM F3502-21, a barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. 

In summary, the present FDA guidance highlights the key points associated with the special regulatory framework for medical devices intended to be used in the context of a public health emergency. The document provides additional clarifications regarding the extraordinary measures temporarily introduced by the authority in order to ensure the uninterrupted availability of vitally important medical devices and also outlines the scope of applicability of the said policy. 


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