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The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the COVID-19 Transition Guidances for Medical Devices: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
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Date: Tuesday, April 18, 2023
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Time: 1:00 – 2:30 p.m. ET
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Registration: No registration required. View webinar details for call-in information.
During this webinar, the FDA will:
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Help prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations.
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Describe recommendations regarding submitting a marketing submission and the timeline for doing so.
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Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline.
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Answer your questions about the guidances on the COVID-19 transition plans.
April 26 Town Hall for COVID-19 Laboratory and Test Developers
In addition to the April 18 webinar, the FDA will host a separate town hall about the COVID-19 transition guidances for laboratory and test developers.
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