November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end . Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
On this page:
We remain committed to expanding access to safe and effective tests through the FDA's traditional premarket review pathway.
EUAs for tests, personal protective equipment (PPE), and more.
Contacts for EUAs, device availability, and more.
For general information:
- COVID-19 Test Basics
- At-Home COVID-19 Tests
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
- Medical Device Safety, including Safety Communications and Letters to Health Care Providers about COVID-19 tests
For test developers:
For health care providers and clinical laboratory staff:
- Policy for Coronavirus Disease-2019 Tests (Revised)
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)
For general information:
Information on respirators and respirator EUAs
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency
- Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
- Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA's Response
- Information for Filing Personal Protective Equipment and Medical Devices During COVID-19
- Registration and Listing of Medical Devices Relating to the COVID-19 Pandemic
- Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel
- Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic
- Considerations for Selecting Respirators for Your Health Care Facility
- COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic
- Digital Health Policies and Public Health Solutions for COVID-19
- FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
- FAQs on Home-use Blood Glucose Meters Utilized Within Hospitals During the COVID-19 Pandemic
- FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data
- Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic
- Non-contact Temperature Assessment Devices During the COVID-19 Pandemic
- Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel
- Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19
- SARS-CoV-2 Reference Panel Comparative Data
- Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
- South Korea's Response to COVID-19
- Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras) | FDA
- UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus