When any mask comes into the United States with N95 marking on it or its box, the . FDA expanded the EUA to include certain non-NIOSH-approved masks .
11 hours ago . Federal officials withdrew approval for more than 60 manufacturers in China to export N95-style masks to the U.S. after finding what they said .
7 Apr 2020 . The regulatory difficulties and continued shortage of PPE in the U.S. led . FDA's revised Enforcement Policy for Face Masks and Respirators During the . when FDA-cleared or NIOSH-approved respirators are not available.
27 Mar 2020 . . the US Food and Drug Administration FDA is lifting requirements for certain masks and respirators to increase their availability. In a 10-page .
27 Mar 2020 . FDA Policy for Face Masks and Respirators in COVID-19 2020 . released in March 2020 by the US Food and Drug Administration FDA . . with regulatory requirements, in instances where the face mask does not create an .
31 Mar 2020 . The U.S. Food and Drug Administration FDA has provided instruction to . Q3: What are the FDA data requirements for PPE such as masks, .
25 Mar 2020 . FDA takes significant action to reduce mask and respirator shortage . in the U.S. Companies should closely follow the requirements outlined in .
10 hours ago . The U.S. Food and Drug Administration on Thursday announced that it has canceled the approval for some manufacturers in China to sell N95 .
11 hours ago . The U.S. Food and Drug Administration has cut the number of mask makers in China that are approved to make N95-type masks for U.S. .
9 hours ago . F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests . in China from exporting N95-style face masks to the United States for medical . The health agencies also tested some KN95 masks that did not have agency approval.
6 Apr 2020 . . including masks and gowns, for U.S. healthcare providers have led to . generally exempt from FDA's establishment and listing requirements .
25 Mar 2020 . FDA is also providing temporary enforcement discretion and . the U.S. Companies should closely follow the requirements outlined in the policy .
2 Apr 2020 . Reach out to us via one of our tip line channels. The Chinese-certified KN95 mask is designed to similar standards as the N95 — which is .
24 Apr 2020 . All medical face mask regulations are designed to test how . US Food and Drug Administration FDA , while surgical face masks . For a respirator mask to be approved, it has to go through what is often called the seal test.