COVID-19: Clearing Up Confusion Regarding Emergency Use Authorization for N95 Respirators and Face Masks

By Marilyn Gatin, Min Yao, and Dorothy Henckel

As the COVID-19 pandemic unfolds, physicians, nurses, and other caregivers nationwide are facing a shortage of N95 respirators and face masks, putting the safety of patients and clinicians at risk.

The “N95” designation means that when subjected to careful testing, the respirator blocks at least 95% of very small (0.3 micron) test particles. 

When an N95 respirator is labeled for use in a hospital setting, it is a Class II medical device regulated by the U.S. Food and Drug Administration (FDA). This is a surgical respirator with the product code MSH. According to 21CFR 878.4040

Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter subject to 878.9, and the following conditions for exemption: 

  • The user-contacting components of the device must be demonstrated to be biocompatible.
  • Analysis and nonclinical testing must:
  • Characterize flammability and be demonstrated to be appropriate for the intended environment of use.
  • Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
  • National Institute for Occupational Safety & Health (NIOSH) approved under its regulation.

When an N95 respirator is labeled for occupational use it is regulated by NIOSH. Both types of respirators are evaluated by NIOSH. NIOSH approval criteria can be found here. 

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