In our earlier Insight, we discussed FDA’s effort to expand the availability of general use face masks and filtering facepiece respirators (including N95 respirators) (“FFRs”) during the COVID-19 public health emergency.
These efforts included: the issuance of various Emergency Use Authorizations (“EUAs”) for certain facemasks, FFRs, and decontamination systems in order to provide flexibility regarding distribution and use of alternatives to N95 respirators and FFRs cleared by FDA or approved by the National Institute for Occupational Safety and Health (“NIOSH”); the issuance of guidance documents related to decontamination and bioburden reduction systems for disinfecting disposable respirators; and the issuance of an enforcement policy related to the use of FFRs and certain other face masks, face shields, and surgical masks.
Now, as access to NIOSH-approved N95 respirators increases across the country, FDA announced that it is revoking EUAs for all imported, non-NIOSH-approved FFRs (including imported disposable respirators such as KN95 masks) and for decontamination and bioburden reduction systems for personal protective equipment. FDA’s press release also announced the revocation of its guidance documents for such systems. FDA cites increased domestic manufacturing of NIOSH-approved N95 respirators as its principal motivation for doing so. With the availability of NIOSH-approved N95 respirators, FDA says, healthcare workers should no longer use non-NIOSH-approved respirators or reuse decontaminated disposable respirators.
This announcement formally revokes the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, revocation effective July 6, 2021;
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, revocation effective July 6, 2021; and
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment, revocation effective June 30, 2021.
As of the respective effective dates, devices previously authorized for use by healthcare personnel under the EUAs will no longer be authorized.
As of June 30, 2021, this announcement also formally revokes the following guidance documents related to decontamination and bioburden reduction systems:
- 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; and
- 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.
Please contact us if you have any questions or would like to discuss further.