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We understand that the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.
The FDA has revoked 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 are no longer authorized for use by health care personnel in health care settings.
Because FDA Registration of their establishments is required to market these products in the United States, manufacturers, exporters and distributors of Personal Protective Equipment (PPE) and Hand Sanitizers are invited to contact our consultants.