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  1. Coronavirus (COVID-19) and Medical Devices

Importing Medical Devices Relating to COVID-19

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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), 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 March 24, 2023, the FDA issued two final guidance documents regarding devices that fall within certain enforcement policies issued during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) and devices issued Emergency Use Authorizations (EUAs) related to COVID-19 (the "COVID-19 Transition Plan guidances"). These guidances provide recommendations to manufacturers that may or may not want to continue to distribute medical devices after the guidances with those COVID-19 enforcement policies are no longer in effect or after the relevant EUA declaration related to COVID-19 terminates. This page provides information on importing medical devices that fell within certain COVID-19 enforcement policies or have been issued an EUA related to COVID-19. The website includes additional information to help prepare manufacturers, brokers, and other import stakeholders for the transition from policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The website also provides examples and procedures related to importing medical devices during the transition period to illustrate the COVID-19 transition policies.

The information provided does not address products that are intended only for general, non-medical purposes (i.e., that are not medical devices), such as use in industrial or manufacturing settings, construction, or home improvement; for those products, importers do not need to transmit FDA-specific entry information.

The FDA has taken action to help expand availability of medical devices that might be of use in addressing the COVID-19 pandemic. Such medical devices generally fall into one of the following categories:

  • Devices that fell within an enforcement policy in COVID-19-Related Guidance Documents. These guidance documents describe circumstances during which the FDA did not intend to object to certain device modifications, or the distribution and use of some types of devices, without compliance with certain regulatory requirements, as explained in each specific policy. When imported, these devices were declared as FDA-regulated with modified entry information specific to the enforcement policy.
    • For more information on COVID-19-related guidances, please refer to the Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417) notice published in the Federal Register on March 13, 2023.
  • Devices that the FDA authorized under an EUA related to COVID-19. When imported, these devices should be declared as FDA-regulated with modified entry information per the EUA.

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