FDA Guidance for Face Masks During Covid-19 Pandemic
There is a lot of controversy over the use of face masks during the current Covid-19 pandemic. Let us understand how they help and how FDA plans to regulate them.
Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. But there is a lot of confusion out there - and many strong opinions - both for and against the use of face masks! Unfortunately, this simple protective device has been heavily politicized in our current polarized environment. To some, it is an intrusion on their personal freedom, but to many others, it is an easy, low-cost way to control the spread of this highly infectious disease.
In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease. When a face mask is intended to be used to prevent the spread of COVID-19, it is being used for a medical purpose. In that case, it becomes a medical device.
Defining “Face Mask”
So, what is a face mask and how can it help prevent the spread of COVID-19? A face mask does not have to be fancy; even a simple cloth covering the mouth and nose can help block or slow down the spread of small liquid droplets that are released in air when we breathe out or sneeze. These liquid droplets carry the virus particles and can spread to people who are nearby. If someone is infected, they may or may not be showing any symptoms. Since we don’t know who is infected and who is not, it makes sense to use a face covering – call it a mask or something else – to reduce the chance that other people nearby may become infected. That is why all of our medical experts are strongly encouraging the use of face masks in public, especially in indoor spaces where social distancing is not possible.
When used for this purpose, a face mask becomes an important tool for public health policy as a source control device. That is, now we can use this simple device to reduce the spread of the virus from a potential source of infection.
Understanding Non-Medical vs. Medical Purposes
This is also a medical purpose, which means a face mask becomes a medical device subject to FDA regulation. FDA has just released a revised Enforcement Policy for Face Masks and Respirators that provides clarity on requirements when these devices are used for a medical purpose during the COVID-19 public health emergency.
Here is a short video that explains different types of PPE used for medical purposes, their requirements and enforcement relief from many of the otherwise applicable medical device regulations for use during the current emergency. This video focuses on face masks and surgical masks. We will cover the other types of medical PPE in another video.
Let us know your questions or comments and subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry.