June 30, 2021

United States Food and Drug Administration (FDA) Revokes Emergency Use Authorizations (EUA) for Disposable Respirators not Approved by NIOSH (Revocation Effective July 6, 2021) and USA for Decontamination Systems and reduction of the microbial load (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health personnel in health establishments. These actions follow the May 27, 2021, letter in which the FDA recommended a transition to disposable respirators not approved by NIOSH as well as the reuse of decontaminated or bioburden disposable respirators.

Based on the increased national supply of respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH), and in accordance with Updated CDC recommendations and in accordance with the recently published Occupational Safety and Health Administration (OSHA) Temporary Emergency Standard (ETS) To protect healthcare workers, the FDA believes healthcare facilities should no longer use crisis capacity strategies. Crisis capacity conservation strategies were previously recommended to address ventilator shortages earlier during the COVID-19 outbreak.

Recommendations

The FDA recommends that healthcare workers and institutions:

  • Use only respirators approved by the FDA or NIOSH, including N95 and other respirators under Emergency Use Clearance (EUA) for NIOSH Approved Air Purifying Respirators for Use in Health Care Settings During COVID-19 Public Health Emergency Response.
  • Transition from wearing disposable respirators for respiratory protection for an extended period to conventional capacity strategies that include wearing a disposable respirator for each patient contact, depending on the CDC strategies, if applicable.
  • Consider redistributing the current inventory of non-NIOSH approved respirators, such as:
    • Non-sanitary facilities for non-medical use (for example, construction)
    • Other countries in need (in accordance with Federal Food, Drug, and Cosmetic Act export provisions)
    • Although it is possible that respirators not approved by NIOSH 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 respirators not approved by NIOSH be reconditioned at this time, as there is currently a sufficient supply of source control medical devices, among others
  • Continue to increase the available inventory NIOSH Approved Respirators, comprising:
    • N95 and other Disposable Filtering Mask Respirators (FFR)
    • Elastomeric respirators, including newer elastomeric respirators without an exhalation valve that can be used in an operating room
    • Supplied Filtered Air Respirators (PAPR).

Background

The FDA continues to work closely with other government partners, including CDC / NIOSH and OSHA, in a whole-of-government approach to help provide essential respiratory protection to meet the needs of healthcare workers.

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 FDA cleared Emergency Use Clearance (EUA) for NIOSH Approved Air Purifying Respirators (includes disposable respirators and those designed to be reusable). Once a respirator has received NIOSH approval, it is automatically cleared under this umbrella EUA. The amount of NIOSH approved respirators available continued to increase throughout the COVID-19 pandemic.

From January 2020 to May 2021, NIOSH approved more than 875 models or configurations of respirators, some of which are manufactured by approximately 20 new national NIOSH approval holders. In addition, to date, more than 6,400 models or configurations of respirators in total are on the list of NIOSH certified equipment that meets NIOSH-Approved EUA criteria and has therefore been approved by the FDA, including:

CDC / NIOSH also updated its Strategies for optimizing the supply of N95 respirators to indicate that health facilities should not use crisis capacity strategies and should quickly resume conventional practices.

OSHA has determined that employee exposure to SARS-CoV-2, the virus that causes COVID-19, poses a serious hazard to workers in health care settings where it is reasonably expected to be that people suspected or confirmed of COVID-19 are present. The move resulted in the release of the ETS, which requires healthcare employers to provide NIOSH or FDA approved respirators for workers potentially exposed to COVID-19.

FDA actions

The FDA believes, in accordance with CDC / NIOSH recommendations and OSHA ETS requirements, that the increased supply and availability of NIOSH approved respirators supports the revocation of EUAs from non-NIOSH approved respirators. Likewise, 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 filter mask respirators (effective July 6, 2021)
  • Non-NIOSH Approved Disposable Filtering Respirator Masks Made in China (Effective July 6, 2021)
  • EUA decontamination and bioburden reduction systems for personal protective equipment (as of June 30, 2021)

* As of April 30, 2021, the FDA revoked the EUA for the Battelle CCDS intensive care decontamination system in response to Battelle’s request for voluntary withdrawal of 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 decontamination of N95 compatible respirators.

Additionally, on June 30, 2021, the FDA withdrew two guidance documents related to decontamination and bioburden reduction:

  • Recommendations for Proponents Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for the industry and Food and Drug Administration personnel
  • Application Policy for Bioburden Reduction Systems Using Dry Heat to Support Single User Reuse of Certain Filter Mask Respirators During Coronavirus Disease (2019) Public Health Emergency

In coordination with these EUA revocations, the FDA intends to update the NIOSH approved EUA so that the scope of products authorized under this EUA is consistent with the actions taken on June 30, 2021. From Similarly, the FDA intends to update the guidance document, Policy for the Application of Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, to align with these actions.

It should be noted that although there is an increase in the national supply of respirators for healthcare workers, the FDA will continue to monitor supply and demand to assess the availability of respirators as facilities move away. systematically crisis and emergency capacity strategies and switch to conventional use. Therefore, respirators, particularly surgical respirators, currently remain on the list of List of missing devices. This list reflects the categories of devices that the FDA has determined to be in short supply 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 healthcare workers and the public informed if new or additional information becomes available.

Report problems to the FDA

The FDA encourages healthcare workers to report any adverse event or suspected adverse event encountered with any medical device, including respirators.

Prompt notification of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact information

If you have any questions about this letter, please contact the Industry and Consumer Education Division (OF).