FDA to allow emergency use of masks from China not approved by CDC

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In May, the FDA got rid of the emergency usage permission for some KN95 masks after they stopped working to fulfill the filtration effectiveness rate of 95 percent. A federal report launched in August found that just one-third of N95 masks made overseas and authorized for emergency situation use permission regularly checked above 95 percent particulate filtering effectiveness..

” Since the beginning of the COVID-19 public health emergency, we have taken proper actions to support the individual protective devices requirements of our health care workers by providing EUAs. As part of our continuing work to meet the needs of this public health emergency situation, we finished a shortage and carried out evaluation and concluded that reissuing this EUA was proper to show the existing U.S. need for these products,” stated Suzanne Schwartz, MD, director of the FDAs Office of Strategic Partnerships and Technology Innovation..

Maia Anderson –
Friday, October 16th, 2020

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The FDAs guidelines for KN95 masks have enabled hundreds of mask brand names to be offered in the United States with little oversight and few quality checks, leaving some states with stockpiles of masks that they no longer trust as protective equipment.
Check out the agencys complete news release here.

The agency formerly approved emergency situation authorization of the masks– which are made in China and are supposed to provide similar levels of defense as N95 masks– if they satisfied any of 3 established eligibility requirements, however the brand-new emergency situation permission no longer consists of that criteria, and the FDA said it will no longer examine demands to contribute to the list of authorized respirators based on those criteria..

The new emergency use authorization approves only respirators that the FDA approved in its Appendix A..

The FDA reissued its emergency use permission Oct. 15 for KN95 respirators made in China that arent authorized by the CDCs National Institute for Occupational Safety and Health..