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FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions

 
• By Elizabeth Orr

The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.

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The US Food and Drug Administration eased up on labeling recommendations but kept a controversial 180-day compliance period in two newly finalized guidance documents aimed at easing the transition out of the COVID-19 public health emergency (PHE), which is set to end in May.

The documents recommend strategies for developing a transition implementation plan, completing a marketing submission, and other key tasks. One applies to products that have been marketed under emergency use authorizations (EUAs), while the other discusses products that were covered by special enforcement policies during the pandemic. Both documents were first released in draft form in December 2021. (Also see "EUA Draft Guidance: FDA Wants ‘Transition Implementation Plan’ Along With Marketing Submission" - Medtech Insight, 22 December, 2021

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