Tag Archives: PPE

Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational … Continue Reading

April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies

As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, … Continue Reading
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