Earlier last week, the US Food and Drug Administration (FDA) issued new and revised guidance on its enforcement policy for face masks, surgical masks, respirators, and face shields during the COVID-19 emergency in response to concerns regarding certain respirators and to separately address decontamination methods. The latest Guidance supersedes FDA’s April 2020 guidance.
The FDA’s position relating to face masks, surgical masks, and face shields is mostly unchanged. There are two key changes, however, as highlighted below.
CDC Alternatives to FDA/NIOSH N95 Respirators
In the May 2020 guidance, FDA no longer recommends using a respirator unless it is FDA-approved, NIOSH-approved, or FDA authorized pursuant to an FDA emergency use authorization. Under the April 2020 guidance, FDA permitted distribution and use of certain non-FDA approved or NIOSH-approved N95 respirators that CDC identified as alternatives to such respirators. The CDC-identified alternatives were approved for use in other countries and may have met standards similar to that imposed by NIOSH. FDA did not require a 510(k) premarket submission for such CDC-alternative respirators.
Based on “concerns regarding the performance of certain respirators based on testing conducted by the CDC,” FDA is discontinuing this non-enforcement policy. Going forward, FDA will require compliance with standard FDA rules and regulations for respirators that are not FDA-approved, authorized under an EUA, or NIOSH-approved. FDA notes, however, that the previously permitted respirators could still be used as a face mask (with relabeling) if they comply with FDA’s EUA for face masks.
Assisting with Decontamination EUAs
The second major change in the May 2020 guidance is the removal of language relating to decontamination methods for otherwise disposable face masks and filtering facepiece respirators. In the April 2020 guidance, FDA requested that manufacturers of decontamination products and methods contact the agency to start the EUA process. FDA also asked potential manufacturers to provide certain information relating to the proposed product or method. The new Guidance eliminates this discussion in light of FDA’s new guidance document focusing on decontamination EUA requests, also issued last week.