Over the past few months, we here at Filti have received many questions concerning mask and respirator certifications. It seems like there is a lot of confusion about what each regulatory agency is responsible for and what these certifications actually mean. It is for this reason that we have put together this informative article so that the average person can have a better understanding of what the processes entail as well as a general time frame for how long it takes to obtain certain certifications. The following is a general overview that will focus on three different agencies: NIOSH, FDA, and ASTM. This document is by no means meant to be a step-by-step guide for each process and instead seeks to provide a general overview and insight into the world of standard PPE device certifications.
The National Institute of Occupational Safety and Health (NIOSH) is a branch of the CDC that is in charge of researching and regulating the workplace environment and conditions in order to prevent work-related accidents, injuries, and sicknesses. One of the most popular buzz words related to the pandemic is “N95”. This is the designation given to respirators that pass NIOSH testing procedures and regulations for fluid resistance, filtration efficiency (bacteria filtration efficiency and particle filtration efficiency), flammability, and biocompatibility. The term refers to a certain class of filters, but if respirators contain N95 class filters inside of them, they are just called N95 respirators by default.
The letter “N” signifies that the respirators are not resistant to oil and the number “95” denotes that the respirators are able to filter 95% of harmful airborne particulates that are as small as 0.3 microns in diameter. For respirators to be N95 compliant, they must pass a synthetic blood, fluid resistance test at a pressure of 160 mmHg. This test corresponds with ASTM level 3 fluid resistance levels. The devices must also pass a flammability test (16 CFR Subpart A) that demonstrates that they do not burn very quickly. A burn time of 3.5 seconds is classified as a pass.
The first step in submitting a NIOSH N95 application is to submit a Manufacturer Questionnaire. This document is a list of several questions that are issued to determine whether or not the manufacturer has safe and effective quality assurance and manufacturing protocols in place for the construction of the N95 device.
Once NIOSH has deemed the questionnaire responses to be satisfactory, the manufacturer is given a 3-letter code. This code is then used to submit a formal request for respirator approval. Finally, all testing samples, required documentation, and appropriate fees are sent away to NIOSH. Then, all that is left to do is to wait! The waiting period for N95 approval usually takes about 3 months from submission to approval.
FDA Medical Device Verification
The FDA is a federal agency that is responsible for ensuring the well-being of the American people. Its main responsibility is to regulate the “safety, efficacy, and security” of manufactured products such as medicine, biological products, and medical devices. It also maintains a close watch on how food is produced and distributed as well as cosmetic products and those that are known to give off certain amounts of radiation.
Under normal circumstances, manufacturers are required to submit a 510(k) or premarket approval application if they would like to market their products as medical devices intended to be used by medical personnel. However, we are not living in normal circumstances anymore. That is why the FDA has issued alternative methods for medical device verification such as abbreviated 510(k) submission forms as well as emergency use authorizations (EUAs).
A 510(k) must be submitted by manufacturers who wish to market and distribute their face mask or respirator to the general public. It is defined as “a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).” While an official 510(k) submission form does not exist, there are requirements and guidelines that manufacturers can follow to ensure successful application approval.
At the onset of the pandemic, the FDA modified their guidelines and began accepting abbreviated 510(k) submissions as the existing respirator and surgical mask supply was quickly engulfed by consumer demand. In one of these abbreviated submissions, a device manufacturer must provide summary reports and demonstrate that their product conforms to pre-determined standards and regulations.
Emergency use authorizations (EUAs) are announcements proclaimed under the authority of the FDA that “allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.” This means that when there is a shortage of personal protective equipment (PPE), certain devices and products can be used if they meet certain criteria outlined by the most recent EUA. Back in March of last year, the FDA released an EUA that stated that all filtering facepiece respirators with particulate protection approved by NIOSH were safe to use in hospitals and other healthcare settings as long as they followed CDC recommendations.
ASTM Standards and Regulations
The American Society for Testing and Materials (ASTM) is an organization that voluntarily develops standards and regulations for businesses to use worldwide. These standards are used by individuals and companies to negotiate contracts, draw up plans, and even to enforce laws established by national governments. As far as this article is concerned, ASTM standards are mainly used to classify fluid-resistant surgical style masks. Masks are put into three different categories: Level 1, Level 2, and Level 3. Level 1 is the least protective with Level 3 being the most protective. ASTM standards observe five key criteria when evaluating masks: fluid resistance, differential pressure (delta P), bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), and flammability (see Table 1).
ASTM is not responsible for approval, certifications, or testing of products that observe their standards. They are, however, associated with the Safety Equipment Institute (SEI) which does offer certification programs for certain products. While the organization does not certify products, per se, they have stated that they are perfectly fine with companies sending their products away for third party testing and claiming to adhere to the relevant ASTM standards. All they ask is that Society logs are not used or displayed on or for these products unless “there is a specific ASTM certifications program through the Safety Equipment Institute” that the manufacturer has completed.
In conclusion, obtaining a certification from any reputable source such as NIOSH or the FDA takes a lot of time and effort to accomplish. Even now, many PPE manufacturers are still applying for these device designations. However, very few make it through the entire process due to the strict nature of certification guidelines. It is set up this way to ensure that any and all certified devices meet the highest standards for fluid resistance, filtration efficiency, biocompatibility, and many other important criteria.
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