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EUA Draft Guidance: FDA Wants ‘Transition Implementation Plan’ Along With Marketing Submission

Also: Makers of life-supporting, life-sustaining EUA devices should file “notification of intent” with agency

 
• By Shawn M. Schmitt

In a long-awaited draft guidance document, the US agency lays bare its thinking on how companies can best ensure that their products granted emergency use authorization status can still be sold post-pandemic (or not).

Red and green wooden figures running through a shaker.
• Source: Alamy

Makers of devices granted emergency use authorization status by the US Food and Drug Administration during the COVID-19 pandemic should submit a “transition implementation plan” to the agency if the manufacturers want to continue selling their products after their EUA is rescinded.

That’s according to a new 16-page draft guidance document released by the FDA on 22 December that lays bare the agency’s thinking on how companies can best ensure that...

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