Due to the novel coronavirus/SARS-CoV-2/COVID-19 rapid infection rate, as well the viruses ability to create asymptomatic carriers, resulting in major societal disruptions and shutdowns have occurred throughout the world, but nowhere has this pandemic hit hardest than within the health care systems, hospitals and clinics. Due to the enormous surge of critical care, there is a massive demand and shortage of Personal Protective Equipment (PPE) including surgical and medical gowns, masks, respirators and other critical ventilator equipment. Due to the high number of infections, the need is especially acute in the United States. This is a result of both limited and aged government stockpiles, limited supplies at the manufacturing facilities due to “Just in time” manufacturing, as well as the shutdown of Asian manufacturers during the pandemic. Conversely, during the beginning of the infection in Wuhan, the Chinese government purchased over two billion surgical masks from countries around the world1. But as soon as China and parts of Asia had managed to slow the spread and lower their curve around mid-March, the United States quickly became the new epicenter, moving the focus of the pandemic and causing skyrocketing demand in the U.S.
Due to the enormous demand of PPE in the US and in order to increase the supply of PPE, FDA initiated an Emergency Use Authorizations (EUA) and FDA Guidance’s to help companies address to the rapidly changing environment. One FDA guidance, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” was issued on April 2, 2020 and accompanies this post.
First it is important to note, that this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS) with the goal of helping to expand the availability of general use face masks for use by the general public, and of filtering face-piece respirators (including N95 respirators) for use by health care professionals in healthcare settings. 2
FDA regulates masks according to their intended us. In order to better distinguish the different types of face masks, the table below from the guidance includes along with the description the corresponding Code of Federal Regulation (CFR) and product code:
Additionally, it is important to recognize that there are two categories or classes of face masks and respirators, those that are non-medical and those intended for medical and surgical use. I will outline what the differences are for the two classes in terms of what this recent guidance outlines.
Starting with the Non-medical Face masks and N95 Respirators, used for general purposes like in commercial and industrial areas, the EUA notes that to avoid import issues it would be advisable to notify FDA prior to importing at: CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov and necessary for non-medical N95 Respirators as well. Along with this recommendation certain product labeling requirements and specific claims must be met to ensure the products are cleared to be sold in the US market.
Regarding the Medical Masks portion of the guidance, which include Face masks/shields, Surgical masks and Surgical N95 Respirators, FDA has opened an email account: CDRH-COVID19-SurgicalMasks@fda.hhs.gov to work with new entrants who wish to import products into the US for all medical products. It is important to also follow the specific product labeling and testing requirements depending on the product and claims made. It is critical that all labeling and files be translated into English and the intended use be clearly stated.
If you require further regulatory consultation or assistance, please reach out to us at email@example.com with your needs and requirements and we will respond to you with a free quote as quickly as possible.
1. China stockpiled 2 billion face masks and 25m medical items. News.com.au. Written April 2, 2020.
2. “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.” U.S. Food and Drug Administration. Issued April 2, 2020.