Search
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results
… evices/medical-device-recalls/empowered-diagnostics-recalls-covid-19-tests-due-risk-false-results … The FDA has identified this … Recalled Product Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 …
At-Home OTC COVID-19 Diagnostic Tests
… /medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests … Español On this page: General …
Counterfeit At-Home OTC COVID-19 Diagnostic Tests
… ronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests … Español The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the …
At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
… dical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions … Español May 12, 2023 - The COVID-19 public health emergency (PHE) declared under section …
Importing Medical Devices Relating to COVID-19
… d-19-and-medical-devices/importing-medical-devices-relating-covid-19 … November 8, 2023- The COVID-19 public health emergency (PHE) declared under section …
Ventilators and Ventilator Accessories for COVID-19
… -and-medical-devices/ventilators-and-ventilator-accessories-covid-19 … The FDA has issued an "umbrella" Emergency Use … timely access to critical devices to help address the COVID-19 pandemic. The FDA outlined its enforcement policy in …
COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2
… /medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2 … This page is part of … asked questions related to uses for different types of COVID-19 tests and the settings in which they can be used. …
Contacts for Medical Devices Related to COVID-19
… vid-19-and-medical-devices/contacts-medical-devices-related-covid-19 … November 8, 2023- The COVID-19 public health emergency (PHE) declared under section …
FAQs on Viral Transport Media During COVID-19
… id-19-and-medical-devices/faqs-viral-transport-media-during-covid-19 … November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section …
Registration and Listing of Medical Devices Relating to COVID-19
… l-devices/registration-and-listing-medical-devices-relating-covid-19 … November 8, 2023- The COVID-19 public health emergency (PHE) declared under section …
COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2
… /medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2 … This … provides answers to frequently asked questions related to COVID-19 test development and review. Questions and answers …
In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
… s-medical-devices/in-vitro-diagnostics-euas-ivds-management-covid-19-patients … March 24, 2023 - The FDA has finalized two … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
… irus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers … Español Antibodies … or after vaccination. SARS-CoV-2 is the virus that causes COVID-19. SARS-CoV-2 antibody tests detect antibodies to the …
COVID-19 Related Test Data and Reporting: FAQs on Testing for SARS-CoV-2
… ical-devices/coronavirus-covid-19-and-medical-devices/covid-19-related-test-data-and-reporting-faqs-testing-sars-cov-2 … … provides answers to frequently asked questions related to COVID-19 related test data and reporting. Questions and answers …
Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - 04/18/2023
… l-devices/medical-devices-news-and-events/webinar-guidances-covid-19-transition-plans-medical-devices-04182023 … Summary … the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices. During this …
COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
… ical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda … The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization …
Pruebas de COVID-19 de venta libre para diagnóstico en casa falsificadas
… devices/coronavirus-covid-19-and-medical-devices/pruebas-de-covid-19-de-venta-libre-para-diagnostico-en-casa-falsificadas … … o utilizando en los Estados Unidos pruebas de COVID-19 de venta libre para diagnóstico en casa …
Pruebas de diagnóstico de COVID-19 realizadas en casa: Preguntas frecuentes
… irus-covid-19-and-medical-devices/pruebas-de-diagnostico-de-covid-19-realizadas-en-casa-preguntas-frecuentes … English 12 de … de salud pública (PHE, por sus siglas en inglés) de COVID-19 declarada bajo la sección 319 de la Ley del Servicio …
FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19
… s-emergency-use-authorizations-euas-medical-devices-related-covid-19 … March 24, 2023 - The FDA has finalized two guidances: … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
… navirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-test-results … Español At-home over-the-counter (OTC) COVID-19 antigen tests, often referred to as rapid tests, …
Pruebas de anticuerpos (serología) para el COVID-19: Información para pacientes y consumidores
… nd-medical-devices/pruebas-de-anticuerpos-serologia-para-el-covid-19-informacion-para-pacientes-y-consumidores … English El … vacunación. El virus SARS-CoV-2 es el virus que causa el COVID-19. Las pruebas de anticuerpos del SARS-CoV-2 detectan …
FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
… d-events/fda-issues-final-guidances-assist-transition-plans-covid-19-related-medical-devices … The following is attributed to … to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic. CDRH finalized these transition guidances …
Using Home-Use Blood Glucose Meters in Hospitals During the COVID-19 Pandemic
… evices/using-home-use-blood-glucose-meters-hospitals-during-covid-19-pandemic … The FDA recognizes that home-use blood glucose … used by patients with diabetes who are hospitalized due to COVID-19 or by those who reside in long-term care facilities …
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
… /medical-devices/safety-communications/do-not-use-e25bio-covid-19-tests-fda-safety-communication … Date Issued: February 4, … (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been …
Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar
… Información general sobre las pruebas de diagnóstico de COVID-19 de venta libre realizadas en casa Pruebas de diagnóstico de COVID-19 sin receta médica realizadas en casa autorizadas y …