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  1. Emergency Situations (Medical Devices)

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:

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:

For test developers:

For health care providers and clinical laboratory staff:


Masks and Respirators

For general information:


Information on respirators and respirator EUAs


Personal Protective Equipment (PPE)


Ventilators and Ventilator Accessories

For general information:

For health care professionals:


Other Medical Devices and Topics

Device or Topic Information
3D printing of medical devices FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
Adverse event reporting for medical devices Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
Digital health Digital Health Policies and Public Health Solutions for COVID-19
Flush syringes Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel
Glucose meters FAQs on Home-use Blood Glucose Meters Utilized Within Hospitals During the COVID-19 Pandemic
Hospital beds, stretchers, and mattresses Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic
Importing medical devices
Medical device manufacturing personnel Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19
Shortages of medical devices
Registration and listing Registration and Listing of Medical Devices during the COVID-19 Pandemic
Blood specimen collection tubes
Supply chain notifications under section 506J of the FD&C Act
Temperature measuring devices Non-contact Temperature Assessment Devices During the COVID-19 Pandemic
Ultraviolet (UV) lamps UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus

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