Detailing the process for NIOSH respirator approval

What are the steps for NIOSH to approve a particulate filtering facepiece respirator?

Answered by Jeffrey S. Birkner, vice president of technical services, Moldex-Metric Inc., Culver City, CA.

Getting a particulate respirator approved by NIOSH requires much work and preparation. Each company that manufactures NIOSH-approved respirators has done a lot of work to develop its respirators, earn NIOSH approval, manufacture and sell these respirators, and continually maintain their quality to remain NIOSH-approved. The specific code manufacturers comply with for NIOSH approval is Code of Federal Regulations 42 part 84, commonly called 42 CFR 84.

Assuming the manufacturer has completed all the design and development work and is ready to apply for NIOSH approval, the company must prepare an extensive package for NIOSH. This includes various performance tests, drawings, packaging and label copy, detailed user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility.

For example, if a manufacturer wants to seek approval on an N95 respirator, which is designed to filter out non-oil-based particulates, it must run filter efficiency tests on the respirator using sodium chloride aerosol. The manufacturer also must perform tests on the resistance of the mask and leakage of the valve, if appropriate. In addition to these tests, the manufacturer prepares an in-depth quality control plan for its manufacturing facility, which addresses the inspection of raw materials and components ensuring they meet stated specifications, inspection and testing of the finished product, and a means of tracking where the respirators are sold. This type of preparation for NIOSH approval is not exclusive to N95 respirators. Whatever approval level the manufacturer applies for – whether it is N, R or P with an efficiency of 95 percent, 99 percent or 99.97 percent – the company must perform tests and create submittal packages that are specific for that approval.

All the data and information is assembled and submitted to NIOSH in a formal, prescribed submittal package along with samples of the respirator. NIOSH not only checks the data, but also performs its own tests to confirm the manufacturer's results. If everything passes, and the drawings and QC plans meet the standards, the manufacturer will receive a testing and certification number, which is noted on the manufacturer's product label. This process generally takes about three months from submittal to approval. If NIOSH has any simple questions, they may allow the manufacturer a reasonable amount of time to answer those questions.

Once the manufacturer receives approval, it can begin to market the respirator. Changes cannot be made to the manufacturing process that would change the performance of the respirator in any way from the way it was originally submitted to NIOSH. Each manufacturer is subject to onsite and field audits by NIOSH. During a field audit, NIOSH purchases respirators in the field and tests them in their government laboratory. If NIOSH finds any inconsistencies on-site or in the field, they can ask the manufacturer to make a correction, stop selling the product and recall existing product from the field.

All these regulations and requirements are designed to ensure the safety of the public when using these respiratory products. However, the employers and end users also must share responsibility by ensuring the respirators are used in accordance with OSHA regulations and the manufacturer's instructions, that they fit properly, and that they are not misused or abused.



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Michele Gardill, PE (Medical Device Pros, LLC)
April 4, 2020
Mr. Birkner did a super job summarizing what it takes to get--and keep--NIOSH approval, from both a technical and a quality perspective. Kudos! Now with COVID-19 upon us, the FDA just issued several EUAs (Emergency Use Authorizations) that authorize certain N95 Filtering Facepiece Respirators (FFRs), including NIOSH-approved disposable FFRs and imported non-NIOSH-approved disposable FFRs, for use in healthcare settings by healthcare personnel. It is evaluating masks & respirators now that it would not previously consider during former, more normal times. The FDA is doing this to help increase availability of these devices to front-line personnel during the public health emergency. It is not certain how long these authorizations will hold. For its part in alleviating the COVID-19 crisis, NIOSH reports that it is quickly evaluating new domestic respirator applications for approval. As Mr. Birkner pointed out, however, the process is rigorous. Competent technical and quality support is still key to preparing a successful NIOSH submittal.

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Jerry
April 5, 2020
Hey there , is there any fast way to apply this we are a kind of largest mask factory in China and just wanna provide as many as masks to support US .

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jane fane
April 9, 2020
Hello, I am helping a medical manufacturer in filing for the NIOSH certification. I would like to know how long a NIOSH application takes. Thank you

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Dalia Galvan
April 28, 2020
Hello, I also would like to know in details the process to apply for NIOSH certification, which are the conditions and regulations I need to have in the factory in order to reach NIOSH certification and prices Looking forward for the information Regards

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Robert Peters
May 19, 2020
Can you recommend a consultant to prepare the NIOSH application package?

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Ruben Arslanian
May 21, 2020
I don't know if anyone's answering these, but I need a consultant to help with the NIOSH certification as well.

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Mufaddal Akber
May 31, 2020
Hi, we are looking for a consultant to help us with NIOSH approval.

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Larry Wu
June 10, 2020
Thank you for the useful information. Wonder if there is any expert or company does this type of consulting services?

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Bandu Birsane
June 25, 2020
I need the contact number and mail ID of NIOSH agent we have to submit the N 95 Mask for their approval.

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Bandu Birsane
June 27, 2020
Hello Sir or Madam, We are looking for NIOSH consultant or agent who will help us to get the approval as early as possible for the mask N95

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ching liu
June 30, 2020
we are in the process of opening up a N95 mask manufacturing facility in Riverside, California. However, we are seeking for a experience, hand on consultant to guide us through the NIOSH approval process. Is that something you can help??

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Raghavendra Kulkarni
July 2, 2020
We would like to enquire about the consultant or agent for the submission of our product N95 Mask for NIOSH approval

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Safety+Health
July 15, 2020
Hi everyone. We reached out to NIOSH. A representative suggested checking out this website, which "has all the procedures and information needed to apply for respirator approvals" and is updated regularly: https://www.cdc.gov/niosh/npptl/respmanuf.html. Still have questions? You can email them to PPEConcerns@cdc.gov. Hope this helps. Thanks for reading S+H.

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Raghavendra Kulkarni
July 25, 2020
How do we can re-apply the request for N95 Mask NIOSH approval, first time NIOSH denied the request, please let us know brief requirement for the request generation as we are first time first product applying to the NIOSH approval

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vanessa
August 25, 2020
Hello, please if anyone found a consultant that helped in the process please email me

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K Karunakaran Karuppannan
June 21, 2021
We are manufacturer of Respirator would like to apply for USA NIOSh approval