8/13/2023 0 Comments Agena covid testingThe Public Health Emergency and Emergency Use Authority We recognize that manufacturers of tests that were issued EUAs will need an appropriate period to transition to normal operations when the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows the FDA to issue EUAs is no longer in effect. The FDA does not plan to take any action that would leave Americans without the tests they need. ![]() Questions and answers regarding other policies described in the Policy for Coronavirus Disease-2019 Tests are found in other pages in this section. This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to Emergency Use Authorizations and Notifications as described in the policies in the Policy for Coronavirus Disease-2019 Tests. Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023.Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). ![]() Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances. The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. Taking other actions with respect to these devices.Developing a transition implementation plan,.The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for: ![]() MaThe FDA has finalized two guidances: 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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