On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...
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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