On March 25, FDA issued immediately effective guidance regarding its enforcement policy for face masks and respirators.  In light of widespread reports of mask and respirator shortages, the purpose of the guidance is to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (N95 respirators) for use by health care professionals.  The guidance applies to the following products:

DA issued immediately effective guidance regarding its enforcement policy for face masks and respirators

FDA acknowledges that face masks and respirators are regulated by FDA when they meet the definition of a medical device and are intended for a medical purpose.  The intended use may be indicated by labeling indicated that the products that are intended for use by a health care professional or in a health care facility or environment.  It may also be indicated by inclusion of any drugs, biologics, or anti-microbial/anti-viral agents.

FDA Does Not Intend To Object To Use Of Non-FDA-Cleared Masks When FDA-Cleared Masks Are Not Available

However, FDA also acknowledges that these same products may be manufactured to the same specifications but not intended for use as a medical device.  Face masks and filtering facepiece respirators are marketed to the general public for non-medical purposes, such as use in construction.  Because these are non-medical uses, FDA does not have jurisdiction over these products.  The agency does not intend to object to individuals’ distribution and use of improvised PPE (a mask that is not FDA-cleared) when no FDA-cleared alternatives are available.

Face Masks (Not Respirators) That Are and Are Not Intended To Provide Liquid Barrier Protection

The guidance delineates specific conditions under which it will not object to the distribution of face masks (but not respirators) that are not intended to provide liquid barrier protection along with surgical masks intended to provide liquid barrier protection, e.g., required labeling and directions, compliance with consensus standards, and compliance with flammability standards.

Reprocessing FFRs and Emergency Use Authorizations (EUA) for Face Masks Intended For A Medical Purpose, Surgical Face Masks and N95 Respirators

The guidance also addresses EUAs of filtering facepiece respirators (FFR) and face masks intended for a medical purpose, surgical face masks and N95 respirators.  FDA is interested in interacting with manufacturers regarding reprocessing of otherwise disposable N95 particulate filtering facepiece respirators to facilitate marketing via an emergency use authorization.  The guidance lists specific reprocessing informational standards that FDA would find useful.

Further, regarding face masks intended for a medical purpose, surgical face masks, and N95 respirators, FDA is seeking to interact with manufacturers whose products do not fall within the prior EUAs to determine whether their products may be able to meet EUA requirements. The guidance lists specific informational elements that FDA would find useful in such discussions.

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