On April 20, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on certain medical face masks. This EUA streamlined and simplified prerequisite requirements for market certain medical face masks during the COVID-19 outbreak period in the US.
Types of Medical Face Masks This EUA Covers & Doesn’t Cover
This latest EUA from the FDA covers face masks meeting the following definition:
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. It may be for single or multiple uses, and if for multiple uses it may be laundered or cleaned. There are many products marketed in the United States as “face masks” that offer a range of protection against potential health hazards. Face masks are regulated by FDA when they meet the definition of a “device” under section 201(h) of the Act. Generally, face masks fall within this definition when they are intended for a medical purpose.
More importantly, you need to pay attention to the type of medical face masks that this EUA does NOT cover:
Surgical masks are not covered within the scope of this authorization. Surgical masks are masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials and are regulated under 21 CFR 878.4040 as class II devices requiring premarket notification. Additionally, these masks meet certain fluid barrier protection standards and Class I or Class II flammability tests.
In summary, this FDA EUA covers face masks that are designed for medical use, either by the general public or by healthcare personnel (HCP), but exclude surgical masks.
Permissible Non-Surgical Medical Face Masks in the US
With this EUA, the FDA is now authorize the use of non-surgical medical face masks in the US, provided they meet the following criteria:
- The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials (which does not include any drugs or biologics);
- The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection, and includes recommendations that would reduce the risk of such use; for example, the labeling might include 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; and use in the presence of a high intensity heat source or flammable gas; or as an alternative example, recommendations for use only by the general public; and
- The product is not labeled in such a manner that would misrepresent the product’s
intended use; for example, the labeling should not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction, nor should it be used for particulate filtration.
Do My Non-Surgical Medical Masks Qualify For The US Market?
With this FDA EUA, as a non-surgical face mask manufacturer or distributor, you are required to complete the following before obtaining an authorization under this EUA to market your masks in the US.
- You must have correct product labeling as a medical mask;
- You must make sure your product label does not contain any mention or statement as a “surgical mask,” with liquid barrier protection and other surgical mask related claims;
- You make required labeling available to each end user or end user, in print and online forms;
- You must include instructions for recommended cleaning and/or disinfection materials and processes, in print and online formats;
- You must have a process in place in the US for reporting adverse events to FDA under 21 CFR Part 803;
- You must do record keeping: ensure that any records associated with this EUA
are maintained and made available to FDA for inspection upon request;
- You must have a process of inventory control for the US customers in place and ready to be inspected by FDA;
How to Correctly Market Your Non-Surgical Face Masks in the US?
No false advertising!
When marketing and promoting your non-surgical medical masks in the US, you must make sure all your marketing and promotional materials are consistent with your non-surgical product labeling requirements listed above. For example, you cannot represent or suggest that your medical face mask is safe or
effective for the prevention or treatment of patients during the COVID-19 pandemic.
Furthermore, you should clearly state in your marketing materials that your non-surgical face masks
- Are NOT FDA cleared or approved;
- Are authorized by FDA under an EUA for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID19 pandemic;
- Are authorized only for the duration of the COVID-19 outbreak, with the FDA-required verbiage.
What Should Non-Surgical Face Mask Manufacturers and Distributors Do?
This latest FDA EUA enables non-surgical face mask manufacturers and distributors to skip the regular FDA Medical Device Class I registration/clearance process in order to market their products in the US market to help fight the COVID-19 outbreak. This being said non-surgical face mask manufacturers and distributors should go through these steps before they are import or market their products in the US:
STEP 1: Make sure you face masks are covered in this FDA EUA;
STEP 2: Make sure your face masks have a product label in English and they meet the labeling and other permissible requirements;
STEP 3: Make sure your product meets all the qualification criteria and you have required post-market process in place for US customers
STEP 4: Make sure you don’t have any inaccurate or false claims in all product materials and marketing collateral, in print and electronic alike.
GreenPPE team specialize in helping face mask and other PPE product manufacturers and distributors enter the US market, in particular utilizing this and other FDA EUAs and Enforcement Policies. We partner with you to get your products authorized for the US market, provide post-market turn-key support, and even link your products to US buyers.
Contact us as firstname.lastname@example.org and let us show you how to quickly supply your medical face masks and other PPE products to the US market.