FDA Update It took awhile but we saw this coming – the EUAs will be ending. Further Guidance Clarification Post COVID Just Announced by FDA Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Today, the U.S. Food and Drug Administration (FDA) divided into two the guidance, Enforcement Policy for
Could this be the start of the FDA rescinding the EUAs? On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types
FDA Update: COVID-19: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse Recently the FDA released news that they are reissuing EUAs revising which types of respirators that can be decontaminated for reuse. Based on the FDA’s further understanding of the performance and design of certain respirators, they have
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection As we move further along with this Corona Virus Pandemic situation, with the “world” trying to get their PPE, most importantly, face masks, the quality of the masks is under suspect. To assure that the masks are providing the protection that they claim
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