CDC Authorizes Use of Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

You probably have heard of the shortages of disposable facemasks for hospital and first responder persons. To exacerbate the problem even further, some old stockpiles in hospitals had elastic that broke or fell apart when doctors attempted to put them on. At an undisclosed Los Angeles hospital emergency room had this happen, as reported by the New York Times:

At a Los Angeles emergency room, doctors were given a box of expired masks, and when they tried to put them on, the elastic bands snapped.

To alleviate the shortage, The FDA (U.S. Food & Drug Agency) is allowing the use of non-NIOSH-approved masks. NIOSH is National Institute for Occupational Safety and Health does research and makes recommendations to the FDA.

In a letter dated March 24, 2020, the FDA said:

On March 24, 2020, in response to this evolving public health emergency and continued filtering facepiece respirator (FFR or respirator) shortages, FDA has concluded based on the totality of scientific evidence available that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the public health or safety (as described under section II Scope of Authorization) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3).

They go on to say:

This EUA does not permit use of authorized respirators by the general public.

We all are glad there will be some degree of protection until the appropriate level masks are available.

The countries that have been approved for masks are Australia, Brazil, Europe, Japan, Korea and Mexico. China is not on this particular list. Note: “Canada is not listed because it allows self-declaration to NIOSH or equivalent standards” so they have been approved before.

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