As the nation’s industry mobilizes to fill the N95 protective mask shortage, the Food and Drug Administration has issued new non-binding guidance.
Below is information extracted from the document. Be sure to read it in full.
FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic. Additionally, this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services.
They believe the policy set forth in this guidance may help address these urgent public health concerns by clarifying the regulatory landscape of face masks and respirators, helping to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (including N95 respirators) for use by health care professionals in healthcare settings.
They recognize that there are multiple types of face masks, those intended for medical use (N95) as well as others. When alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.
Wherever possible, health care facilities should continue to use FDA-cleared face masks and NIOSH-approved and/or FDA-cleared N95 respirators or better. In response to the COVID-19 pandemic, FDA has also issued EUAs that authorize certain N95 Filtering Facepiece Respirators, including NIOSH-approved disposable FFRs9 and imported non-NIOSH-approved disposable FFRs10, for use in healthcare settings by healthcare personnel and are intended to help increase availability of these devices to front-line personnel during the public health emergency.
FDA requests that makers of alternative masks contact them to determine if they meet Emergency Use Authorization specifications.
The information on how to submit is in the guidance. Read it here.