Legal Update

Apr 7, 2020

CDC Provides Recommendations for Respirators When N95 Respirators Are Not Available in COVID-19 Crisis

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To combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide suggested alternatives to using N95 respirators authorized by the US Food and Drug Administration or approved by the National Institute for Occupational Safety and Health when such respirators are unavailable. Importantly, the FDA has issued guidance that it will not object to the distribution, importation, or use of respirators that are identified in the CDC’s N95 Respirator Strategies. Accordingly, manufacturers, importers, and sellers have an alternative to requesting an Emergency Use Authorization from the FDA for non-FDA-authorized or NIOSH-approved N95 respirators.

Alternatives to FDA-authorized or NIOSH-approved N95 respirators include the following:

  • Other NIOSH-approved alternatives to N95 respirators. The N95 respirator is only one type of respirator approved by the NIOSH and compliant with OSHA requirements. A list of other NIOSH filtering facepiece respirators that can be substituted for the NIOSH-approved N95 respirator is published by NIOSH and available here
  • Expired FDA-authorized or NIOSH-approved N95 respirators. While the CDC warns that expired N95 respirators may not perform to certification requirements, such expired respirators can be used during expected shortages. 
  • Extended use of FDA-authorized or NIOSH-approved N95 respirators. Healthcare providers may develop policies that allow for extended use of FDA-authorized or NIOSH-approved N95 respirators, i.e., permitting the respirator to be used continuously when treating several patients. The CDC has set forth guidance on implementation of extended use.
  • Respirators approved in other countries that are similar to NIOSH-approved respirators. As part of the CDC’s N95 Respirator Strategies document, the CDC provides a list of countries that evaluate respirators using standards that are “expected to provide protection similar to NIOSH-approved” respirators. This includes certain respirators from Australia, Brazil, China, Europe, Japan, South Korea, and Mexico.
  • Reuse of FDA-authorized or NIOSH-approved N95 respirators. Reuse of FDA-authorized or NIOSH-approved N95 respirators is permitted in crisis scenarios. The number of reuses is typically recommended by the manufacturer, and the CDC offers guidance on reuse strategies as well. 

As the COVID-19 crisis evolves, Seyfarth attorneys are closely monitoring the CDC’s reactions to the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our COVID-19 Resource Center for more information.