Unless you've been living under a rock for the past year, you know the Coronavirus Pandemic is a really big deal. The vaccines are finally being rolled out, but for the majority of this time we have had masks and other Personal Protection Equipment (PPE) as our main tools in the fight against the virus. As we wait for everyone to get their vaccine, masks are still in use. Some people say masks don't work, though. Do they? One way to know for sure whether they do or not is to know whether they are FDA Approved. After all, we trust the FDA to tell us what ingredients are in food and whether or not our medicine really does what the makers claim it will. Doesn't it make sense to trust the FDA in the fight against COVID-19 as well?
To help address concerns about availability during the COVID-19 pandemic, the FDA has issued emergency use authorization (EUAs) for certain PPE products including masks. Additionally, the FDA has issued recommendations and policies about PPE in general. On August 5, 2020, the FDA issued an umbrella emergency use authorization for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are technically “FDA Approved.”
Beyond masks, some face shields and respirators have been issued an EUA as well. Wait, is there a difference between a face mask, a surgical mask, and a respirator? Yes. Face masks, surgical masks, and respirators all cover a wearer's nose and mouth, but they differ in several aspects. A face mask that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks that are not intended for a medical purpose are not considered medical devices. However these face masks can and should be used by health care personnel as well as the general public as source control in accordance with CDC recommendations on Interim Infection Prevention and Control. Surgical masks intended for medical purposes are considered medical devices. The mask meets certain fluid barrier protection standards.
There are also respirators, known as filtering facepiece respirators (FFRs), including N95s and surgical N95s. These filter at least 95 percent of airborne particles. They are PPE that tightly fit the face and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic airborne particles in a health care setting.
That's great news for the entire world as we continue to fight against the spread of this disease. If your company manufactures a face mask, face shield, or surgical mask you feel should be FDA approved, it's time to reach out to FDA attorneys. FDA attorneys can help you navigate this complicated system and get your products to the people who need it the most as we continue to fight this virus.
