FDA revokes Emergency Use Authorizations for KN95s
The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021).
Official FDA Release
June 30, 2021
The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021, letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators.
Based on the increased domestic supply of respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH), and consistent with CDC’s updated recommendations and in alignment with the Occupational Safety and Health Administration’s (OSHA) recently published Emergency Temporary Standard (ETS) to protect health care workers, the FDA believes health care facilities should not use crisis capacity strategies any longer. Crisis capacity conservation strategies were previously recommended to address respirator shortages earlier during the COVID-19 outbreak.
The FDA recommends that health care personnel and facilities:
- Use only FDA-cleared or NIOSH-approved respirators, including N95s and other respirators under the Emergency Use Authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.
- Transition from wearing disposable respirators for respiratory protection for an extended time to conventional capacity strategies that include wearing a disposable respirator for each patient contact, according to the CDC’s strategies, as appropriate.
- Consider redistributing current inventory of non-NIOSH-approved respirators, such as, to:
- Non-health care settings for non-medical use (for example, construction)
- Other countries in need (in accordance with the Federal Food, Drug, and Cosmetic Act export provisions)
- While it is possible that non-NIOSH-approved respirators may be reconditioned for use as source control (see, for example as face masks in Import Alert 89-18), the FDA does not recommend that non-NIOSH-approved respirators undergo reconditioning at this time because there is currently sufficient supply of source control medical devices, among other things
- Continue to increase inventory of available NIOSH-approved respirators, including:
- N95s and other disposable filtering facepiece respirators (FFRs)
- Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in an operating room
- Powered air-purifying respirators (PAPRs).
The FDA continues to work closely with other government partners, including CDC/NIOSH and OSHA, in a whole-of-government approach to help make available critical respiratory protection to address the needs of health care personnel.
If a reusable respirator is needed, organizations should first try to acquire respirators like elastomeric respirators and PAPRs, which are designed to be reusable.
NIOSH-approved respirators, including N95 respirators, remain authorized under the FDA emergency use authorization (EUA) for NIOSH-Approved air purifying respirators (includes single-use respirators and those designed to be reusable). After a respirator receives NIOSH approval, it is automatically authorized under this umbrella EUA. The quantity of available NIOSH-approved respirators has continued to increase throughout the COVID-19 pandemic.
From January 2020 through May 2021, NIOSH has approved over 875 respirator models or configurations with some of these manufactured by approximately 20 new, domestic NIOSH approval holders. In addition, as of today, there are over 6,400 total respirator models or configurations on the NIOSH certified equipment list which met the NIOSH-Approved EUA criteria and thus had been FDA-authorized, including:
- Over 600 FFR models (of which there are over 530 N95 FFR models)
- Over 5,500 elastomeric respirator configurations, including new elastomeric respirators without an exhalation valve
- Over 360 PAPR configurations
CDC/NIOSH has also updated its Strategies for Optimizing the Supply of N95 Respirators to indicate health care facilities should not be using crisis capacity strategies and should promptly resume conventional practices.
OSHA has determined that employee exposure to SARS-CoV-2, the virus that causes COVID-19, presents a grave danger to workers in health care settings where people with suspected or confirmed COVID-19 are reasonably expected to be present. This determination resulted in publication of the ETS, which requires health care employers to provide NIOSH-approved or FDA-authorized respirators for workers potentially exposed to COVID-19.
The FDA believes, consistent with CDC/NIOSH recommendations and OSHA ETS requirements, that the increased supply and availability of NIOSH-approved respirators supports the revocation of the non-NIOSH-approved respirator EUAs. Similarly, all manufacturers of decontamination and bioburden reduction systems have requested revocation of their EUAs.
On June 30, 2021, the FDA announced the revocation of the following EUAs:*
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
*On April 30, 2021, the FDA revoked the EUA for the Battelle CCDS Critical Care Decontamination System in response to Battelle’s request for voluntary withdrawal of the authorization. In response to changing customer needs, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. On February 12, 2021, the FDA revoked the EUA for the NovaSterilis Nova2200 for Decontaminating Compatible N95 Respirators.
In addition, on June 30, 2021, the FDA has withdrawn two related decontamination and bioburden reduction guidance documents:
- Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
- Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease (2019) Public Health Emergency
In coordination with these EUA revocations, the FDA intends to update the NIOSH-approved EUA such that the scope of the products authorized under that EUA is in alignment with the actions taken on June 30, 2021. Similarly, the FDA intends to update the guidance document, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, to align with these actions.
Of note, while there is an increase in domestic supply of respirators for health care personnel, the FDA will continue to monitor supply and demand to assess respirator availability as facilities systematically transition away from crisis and contingency capacity strategies and move towards conventional use. Therefore, respirators, specifically surgical respirators, presently remain on the FDA’s Device Shortage List. This list reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been or will be affected.
The FDA will continue to keep health care personnel and the public informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care personnel to report any adverse events or suspected adverse events experienced with any medical devices, including respirators.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.