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FDA Clears First COVID-19 Home Antigen Test
… /news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test … Español Today, the U.S. Food and Drug … the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home …
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 …
La FDA autoriza la primera prueba de antígenos COVID-19 para el hogar
… nnouncements/la-fda-autoriza-la-primera-prueba-de-antigenos-covid-19-para-el-hogar … English Hoy, la Administración de … sin receta médica (OTC, por sus siglas en inglés) para COVID-19. La prueba de antígenos COVID-19 para el hogar …
Innovation to Respond to COVID-19
… mergency-preparedness-and-response/coronavirus-disease-2019-covid-19/innovation-respond-covid-19 … This page is no longer being updated.These …
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 …
MQSA Inspection Information Related to COVID-19
… andards-act-and-program/mqsa-inspection-information-related-covid-19 … The U.S. Food and Drug Administration (FDA) has received inquiries about the impact of COVID-19 on mammography facilities. On March 18, 2020, the …
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 …
Voluntary Recall of Three Detect Covid-19 Test Lots
… ket-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots … Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to …
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 …
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
… the U.S. Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include … indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 …
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 …
SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’
… d-biosensor-issues-notification-voluntary-recall-standard-q-covid-19-ag-home-test … January 31, 2022. SD Biosensor, Inc., a … company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed …
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 …