Lexology January 3, 2022
Holland & Knight LLP

New Rules Likely to Impact PPE, Diagnostic Tests, Ventilators and Other Devices

Highlights

  • The U.S. Food and Drug Administration (FDA) has announced a plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special rules during the COVID-19 pandemic.
  • The FDA’s draft guidances address transitioning such devices brought to market during the public health emergency (PHE) caused by COVID-19 once the PHE is over. During the PHE, FDA has used two vehicles – enforcement policies and Emergency Use Authorizations (EUAs) – to allow certain otherwise unapproved or unauthorized devices to be lawfully marketed.
  • The newly released guidances will likely apply to personal protective equipment (masks, face shields,...

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Topics: FDA, Govt Agencies, Healthcare System, Medical Devices, Public Health / COVID
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