All manufacturers of decontamination and bioburden reduction systems have requested, and the FDA has proceeded with, the revocation of their EUAs, effective June 30, 2021.
Since the beginning of the pandemic, NIOSH has approved more than 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 more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list which have met the NIOSH-approved EUA criteria and thus are FDA-authorized. These include:
more than 600 filtering facepiece respirator (FFR) models (of which there are over 530 N95 FFR models),
more than 5,500 elastomeric respirator configurations, including new elastomeric respirators without an exhalation valve, and
more than 360 powered air purifying respirator configurations.
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Today’s EUA revocations announcement for all non-NIOSH approved disposable FFRs follows earlier actions to limit authorization of imports of non-NIOSH-approved filtering facepiece respirators, imports of non-NIOSH approved filtering facepiece respirators manufactured in China, and decontamination and bioburden reduction systems for disposable respirators.
FDA has also withdrawn two related decontamination and bioburden reduction guidance documents: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
The FDA recommends health care personnel transition from extended use of disposable respirators to single-use for single-patient interactions as appropriate. See the letter to health care personnel for additional information.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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