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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)
… guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests-revised … March 24, 2023 - The FDA has finalized two … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
Policy for Coronavirus Disease-2019 Tests (Revised)
… Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical … Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) . The guidances outline the FDA's general …
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
… diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide …
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
… diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide …
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency
… masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public … September 5 Update : The FDA is updating and … and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency" (latest version published …
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
… used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions
… required to have an approved HDE at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …
Enforcement Policy for Clinical Electronic Thermometers
… clinical electronic thermometers at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …