The FDA encourages stakeholders to plan for the transition process by reviewing the two final guidances, attending the upcoming webinar, and contacting the FDA if they have questions. If manufacturers with impacted devices plan to continue distributing their devices after either the end of the transition period following the expiration of the COVID-19 PHE or termination of the relevant device EUA declaration related to COVID-19, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
Upcoming webinar on these guidances
On April 18, 2023, the FDA will host a webinar for stakeholders interested in learning more about the guidances.
Questions?
If you have questions about these final guidances, contact the Division of Industry and Consumer Education.
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