The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023. The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after ...
With the COVID-19 public health emergency set to expire on May 11, medical technology companies that brought devices to market under special pandemic rules will need to prepare transition plans soon, ...
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