FDA No Longer Accepting Certain Face Mask EUAs, Signaling A More Manageable Pandemic
The US agency says it’s no longer going to update its list of certain imported respirators that are allowed on the market under an emergency use authorization for health care workers, or accept new applications for the face masks.
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BioFire’s test detects a range of respiratory and bacterial infections, including SARS-CoV-2. Its clearance is the first example of how other products with EUAs can stay on the market after the pandemic.
Makers of devices and tests granted emergency use authorization by the US FDA are being urged by the agency to not wait until the COVID-19 public health emergency is over to get their products approved – assuming they want to keep them on the market post-pandemic.
After CDC concerns about the quality of Chinese-manufactured respirators, the US FDA has pulled a number of products from its list of authorized respirators for health care providers. The agency said the remaining authorized respirators made in China are no longer eligible for use after being decontaminated due to concerns about their ability to hold up after decontamination.