evidence: On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024. [...] FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends. [...] March 24, 2023 - The FDA 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). 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: