May 12, 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 end of the PHE under section 319 of the PHS Act does not impact the FDA’s ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
March 24, 2023 - The FDA has 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:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
EUAs for tests, personal protective equipment (PPE), and more.
Contacts for EUAs, device availability, enforcement policies, 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:
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach (Archived)
- Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing (Archived)
- Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers (Archived)
- Policy for Coronavirus Disease-2019 Tests (Revised)
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)
- Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
For general information:
- Face Masks, Including Surgical Masks, and Respirators for COVID-19
- Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication
- Considerations for Selecting Respirators for Your Health Care Facility
- Manufacturing and Distributing Respirators for Health Care Use in the United States During the COVID-19 Pandemic
Information on respirators and respirator EUAs
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency
- Personal Protective Equipment EUAs
- Medical Gloves for COVID-19
- Strategies for Optimizing the Supply of Eye Protection (CDC)
- Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
For general information:
For health care professionals:
- Ventilator Supply Mitigation Strategies (Archived)
- Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers
- Ventilators and Ventilator Accessories EUAs
- Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID) Public Health Emergency
- Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
- Importing Medical Devices During the COVID-19 Pandemic
- 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
- Digital Health Policies and Public Health Solutions for COVID-19
- COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic
- 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
Guidance documents issued by the FDA describe the agency's interpretation of or policy on a regulatory issue. The title of the guidance often indicates the intended audiences for the guidance, such as industry (medical device manufacturers and distributors), clinical laboratories, and FDA staff.
To address the COVID-19 public health emergency, the FDA has determined that prior public participation for most of the following guidance documents is not feasible or appropriate.
Many of these guidance documents are immediately in effect, but they remain subject to public comment in accordance with the FDA's good guidance practices.