What it takes for N95 respirator to be cleared by the FDA

The coronavirus pandemic started earlier in the year around February. Since then, face masks have become part of our daily lives, and we’re slowly getting used to this new normality. This item has certainly been on the news a lot this year, whether it’s about surgical masks, medical masks, reusable ones, or whether or not we can use face shields.

But, one of them, the N95 mask, has been the clear protagonist of the year. Shortages, scams, production increase, scarce raw materials, and the list goes on and on. This valuable item has all the right to be the center of attention, since they’re the best face masks for protection against the coronavirus, and healthcare workers need them.

To be used in healthcare settings, N95 masks need to meet certain requirements, and one of them is to be cleared by the FDA. In this article, we’ll talk about N95 masks, and what steps can be taken to obtain FDA clearance for them during the coronavirus pandemic.

N95 masks

Right now, N95 masks are the best disposable face masks for virus protection. Other options, like surgical masks, KN95 masks, or reusable cloth masks, don’t have many antiviral properties, and that’s why they’re recommended to be used by the general public. N95 masks, on the other hand, are being prioritized for healthcare workers who are in constant exposure to the virus.

The National Institute for Occupational Safety and Health (NIOSH) is an institution that makes sure workplaces are safe and aims to prevent work-related injuries or illnesses. Part of their job is to test and regulate respirators, making sure they meet the criteria of each type of respirator according to their filtration rate classification.

This classification takes into consideration two main properties:

  • Resistance to oil: which is indicated by one of three letters: N, for not resistant, R for resistant, and P for oil-proof. N95 respirators are not resistant to oil.
  • Percentage of minimum particulate filtration efficacy: which can be either 95, 99, or 100%. N95 respirators can filter out at least 95% of the airborne particles present in the air.

Based on this classification, N95 masks are very effective for protection against non-oil based airborne particles, such as smoke, dust, or certain pathogens like the flu virus or the new novel coronavirus.

Every N95 respirator needs approval by NIOSH to be distributed as such inside the USA. For medical use, N95 respirators need additional approval by the Food and Drug Administration. However, with the coronavirus crisis, many N95 respirators have been cleared by the FDA under the Emergency Use Authorization.

Emergency Use Authorization and how to obtain one

The Secretary of the Department of Health and Human Services (HHS) stated that the coronavirus pandemic is a public health emergency with significant potential to affect the health of United States citizens, according to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act.

Based on this, the Secretary of the Department declared that these circumstances would justify authorization of emergency use of PPE, medical supplies, in vitro diagnostics for the detection of COVID-19, and others. This includes alternative products to be used as medical devices as well.

These Emergency Use Authorizations (EUA) provide the FDA with the authority to facilitate availability and use of products needed during public health emergencies like this one, to strengthen the public health of the nation.

The section 564 of the FD&C Act, the FDA Commissioner can allow medical products that were previously unapproved to be used during the emergency to either treat, diagnose, or prevent diseases that can be life-threatening. The section can also allow unapproved uses of approved products. This is all under the condition that there are no approved and adequate alternatives available.

The FDA is very clear in saying that, to issue EUAs when public health emergencies happen, they need a separate determination and declaration under section 564 of the FD&C Act, and other criteria need to be met.

To be able to manufacture and distribute respirators to be used for healthcare inside the USA under an EUA, there are certain characteristics and requirements. The FDA has a complete flowchart that provides information on how to do this, as well as links to more detailed information provided by the CDC, FDA, and NIOSH.

The flow chart starts by asking if the respirator is intended to be a disposable filtering facepiece respirator, like N95 masks for example. If the answer is no and the respirator is a reusable one, they need NIOSH approval first and then it can opt for an EUA. If the answer was yes, then they can go to the next question.

Then they ask if NIOSH approved the respirator, and if the answer is yes, the respirator is already authorized under the EUA for NIOSH-approved respirators. If the answer is no, the pathway for an EUA will depend on the country the respirator is manufactured. If it’s the United States, the respirator needs approval by NIOSH or FDA clearance, and once it obtains NIOSH approval, it will be authorized under the EUA for NIOSH-approved respirators. If the respirator is manufactured outside the US, it will need either clearance by the FDA or be authorized under the Non-NIOSH-approved respirators.

We would like to remind our readers that kids need to use face masks in a smaller size, which can be bought easily online. You can also find many other options for sale to buy in bulk or wholesale, including 3M N95 masks like the 3M 8210 and 3M 8511. 

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