Shopping for a high-performing mask is a daunting task and claims of FDA approval would certainly make life easier but, spoiler alert, there’s no such thing as “FDA-approved” masks! There are however a number of FDA hoops that manufacturers can jump through to indicate some degree of quality and performance.
The goal of this post is to help you navigate the complexities of the different FDA designations used for masks and the resulting true or false claims made by mask manufacturers and sellers. The FDA’s primary mission is to protect the public. However, the framework required to do this involves a very complex and detailed regulatory system written in specialized legal language that is baffling to those unfamiliar with the nuances of the regulatory world.
The FDA’s mission and regulatory designations
The FDA’s mission statement makes it clear that it is responsible for protecting public health. This includes regulating drugs, medical devices, the food supply, and cosmetics. It also can support innovation contributing to public health. However, while it REGULATES many things, it APPROVES a much shorter list of items deemed to be higher risk such as drugs and implantable medical devices. (Click the following link for more information: Is It Really ‘FDA Approved?’ | FDA)
When it comes to masks, the FDA provides regulations, but not approvals. It is deceptive marketing for a manufacturer to claim that a mask is “FDA-Approved”. In fact, it’s illegal.
|What about respirators? Respirators (e.g. N95s) do require approval which is granted by NIOSH, not the FDA. You can learn more about approval for respirators from this CDC page and you can find a list of NIOSH-approved respirators on this CDC page.|
Levels of FDA oversight for masks
Masks may be designated as:
- FDA Authorized
These designations are determined based on the type of mask considered by the FDA (the mask classification), and whether or not additional criteria are met. In general, “FDA-Cleared” masks are held to more rigorous standards than “FDA-Authorized” or “FDA-Listed” masks. It is worth noting that while some masks may be held to more rigorous standards, it does not necessarily follow that the less rigorous standards are inherently bad. Rather, this reflects the fact that different masks are required for different tasks. A cloth mask used in a community setting where universal masking is mandated does not necessarily need to meet the same standards as the physician’s mask used in a hospital setting.
|What about FDA-Registered? This designation does not apply to masks, rather, it applies to manufacturers. It simply means that the manufacturer is registered with the FDA. According to the FDA, “When a facility registers its establishment and lists its devices, the resulting entry in the FDA’s registration and listing database does NOT denote approval, clearance, or authorization of that facility or its medical devices”|
- This is the most rigorous designation for masks and is the typical designation used for medical masks for use in health care settings. These masks include: surgical masks (FDA Product Code: FXX), surgical masks with antimicrobial/antiviral coatings (OUK), and pediatric face masks (OXZ).
- The recognized standards for these masks are: ASTM F2100, ASTM F2101, and ASTM F1862. The ASTM F2100 is the most common standard for FDA-cleared masks and was discussed in this previous blog post
|The FDA clears adult surgical masks and pediatric face masks that have been tested and meet specific barrier criteria against particulates and microorganisms. These masks are considered Class II medical devices and can be marketed as “FDA-Cleared” if they have been granted FDA 510(k) clearance. To determine if a mask has been “FDA-Cleared”, search for the mask’s product code in either the Devices@FDA Database or the “FDA 510(k) PreMarket Notification” database.|
- These are masks that are/were allowed under Emergency Use Authorizations (EUAs) for COVID-19. These masks are typically designed for use in healthcare settings when appropriate FDA-cleared options are not available and are classified as EUA authorized surgical masks (QMF).
- These masks satisfy the requirements of their respective EUAs, but they may not meet all of the typical FDA and ASTM standards. Authorization may not apply beyond the COVID-19 emergency. See specific EUAs for details.
|Masks can be marketed as “FDA-Authorized” if they comply with the appropriate Emergency Use Authorizations (EUAs) for COVID-19. Although these masks must adhere to some requirements, they may not be held to the typical standards required outside of the current public health emergency. The FDA provides a list of FDA-Authorized masks that may be considered as personal protective equipment (PPE), specifically “FDA-Authorized” Surgical Masks . Click here for the list of FDA-Authorized PPE. As PPE shortages resolve, these EUAs may be revoked; see the FDA for the most up-to-date information.|
- This is the least rigorous mask designation. It is typical for masks intended for use as source control in response to the current COVID-19 pandemic, or in cases where neither FDA-cleared nor FDA-authorized masks are available.
- These masks (Product Code: QKR) satisfy the requirements of the FDA’s Enforcement Policy for Face Masks.
- The recognized standard for these masks is ASTM F3502. However, this standard is new, introduced in 2021, and not enforced but rather used as a guideline. For more information on the ASTM F3502 standard, which can be applied to either disposable or reusable masks, see this previous blog post.
|These are masks that are marketed by a company that has completed a 30 minute registration process, paid the appropriate registration fee (e.g., for 2021 the fee is $5,546), and gone through the required steps to list their masks with the FDA. “FDA-Listed” is traditionally used when marketing low risk medical devices (i.e., class I medical devices) such as face shields. However, in the context of the COVID-19 pandemic, it also includes a number of masks and face coverings that are “not classified”. To verify that a mask is “FDA-Listed” go to the FDA registration and listing database and search for the manufacturer, or search by the product code (click here to search the FDA’s Registration and Listing Database).|
In summary there are three different FDA designations that are applied to masks: FDA-cleared, FDA-authorized, and FDA-listed. These designations are typically applied to disposable medical masks, however it is theoretically possible for a reusable fabric mask to be designated as FDA-listed. The table below summarizes the different mask designations, recommended standards for the different mask types, and the FDA’s product codes for each mask type. If a mask claims to have an FDA designation, you should be able to verify the claim by looking up the mask manufacturer in the appropriate FDA database described in the boxes of the appropriate sections above.
|Maximum Marketing Designation*||Medical Device Class||FDA Submission Type||Mask Information|
|Recommended Standard||Description||Product Code|
|FDA-Cleared||II||510(k)||ASTM F2100, ASTM F2101, ASTM F1862||Mask, Surgical||FXX|
|Surgical mask with antimicrobial/antiviral agent||OUK|
|FDA-Authorized||Not Classified||EUA||See EUA||Mask, Surgical, Eua Authorized||QMF|
|FDA-Listed||Not Classified||Enforcement Discretion**||ASTM F3502||Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency||QKR|
|*This column refers to the “best” marketing label a mask in the category can achieve. However, any mask from the FDA’s Registration and Listing Database can be marketed as “FDA-Listed.”
** Enforcement discretion means that even though the item (e.g.., mask) meets the FDA definition of a medical device, the FDA can choose not to enforce their usual requirements unless public health concerns arise because the risk of the current use is considered low. However, these masks should still follow the guidance laid out by the Enforcement Policy.
Additional References and Resources
- “Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved?” https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
- “FDA REGISTERED, CLEARED, APPROVED: WHAT’S THE DIFFERENCE?” https://www.truthinadvertising.org/fda-registered-cleared-approved-whats-difference/
- FDA “Product Classification” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
- “Registration and Listing of Medical Devices during the COVID-19 Pandemic” https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/registration-and-listing-medical-devices-during-covid-19-pandemic
Searchable FDA Databases
- “FDA-Cleared” masks may be catalogued in the Devices@FDA Database or the “FDA 510(k) PreMarket Notification” database
- “FDA-Authorized” masks are described on the pages describing special Emergency Use Authorization (EUA) pages including “Personal Protective Equipment EUAs” and more generally at “Face Masks, Including Surgical Masks, and Respirators for COVID-19”
- “FDA-Listed” masks are catalogued in the “FDA Establishment Registration & Device Listing” database