Coronavirus (COVID-19) and Medical Devices
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.
Additional Resources:
- 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
On this page:
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Info on specific devices
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For all devices
Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19
EUAs for tests, personal protective equipment (PPE), and more.
Contacts for Medical Devices During COVID-19
Contacts for EUAs, device availability, enforcement policies, and more.
Medical Device Shortages During the COVID-19 Public Health Emergency
Categories of devices the FDA has determined to be in shortage at this time.
COVID-19 Tests
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
- Report: South Korea's Response to COVID-19: Focus on Testing Strategy and Lessons Learned
For test developers:
- FAQs on Testing for SARS-CoV-2
- FAQs on Viral Transport Media during COVID-19
- SARS-CoV-2 Reference Panel Comparative Data
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
- 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
- Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
Guidances:
- Policy for Coronavirus Disease-2019 Tests (Revised)
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) - Guidance for Test Developers and Food and Drug Administration Staff
- 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 - Guidance for Industry and Food and Drug Administration Staff
Masks and Respirators
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
Flowcharts:
- 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
Guidance:
Personal Protective Equipment (PPE)
- Personal Protective Equipment EUAs
- Medical Gloves for COVID-19
- Strategies for Optimizing the Supply of Eye Protection (CDC)
Guidance:
Ventilators and Ventilator Accessories
For general information:
For health care professionals:
- Ventilator Supply Mitigation Strategies
- Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers
- Ventilators and Ventilator Accessories EUAs
Guidance:
Other Medical Devices and Topics
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.