On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)" and "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19)".
Emergency Use Authorization (EUA) is a mechanism that allows the US Food and Drug Administration (FDA) to authorize the use of medical products during public health emergencies, such as the COVID-19 pandemic.
The FDA acknowledges that having to adjust from COVID-19 pandemic policies to "normal operations" will take some time for manufacturers, distributors, healthcare facilities, healthcare providers, patients, and consumers.
In order to provide a clear policy to all stakeholders and FDA staff, FDA is issuing this guidance. The FDA provides general recommendations for this transition process regarding devices issued emergency use authorizations (EUAs) related to COVID-19, as well as recommendations regarding the submission of a marketing submission, as applicable, and other actions.
During the COVID-19 public health emergency (PHE), FDA issued a companion transition guidance that explains FDA's recommendations for devices falling within certain enforcement policies. FD&C Act and its implementing regulations require manufacturers and other stakeholders to comply with certain transition guidance in order to prepare for a smooth transition to normal operation.
In order to more about the Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) click this LINK.
To know more in detail about the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19), click this LINK.
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