Importing COVID-19 Supplies
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
IMPORTERS: Shipment of COVID-19 supplies held-up at a port-of-entry?
For assistance, contact the FDA office covering your port of entry.
Visit the FDA Import Offices and Ports of Entry page for contact information and instructions. It includes an interactive map that importers can use to find the right office for their shipment based on where the product is entering the United States.
To ensure timely assistance with an urgent need of COVID-19 supplies during the COVID-19 pandemic, please have the necessary information available, such as the:
- entry number (which you can get from your entry filer),
- port of entry, and
- other shipment details.
The FDA receives many different types of entries (consumption, informal, warehouse, import for export, etc.). Most questions revolve around the difference between commercial and personal shipments.
- Commercial Shipments: Imported goods brought into U.S. commerce for sale or distribution. To find out more information about the different types of entries visit our Common Entry Types page.
- Personal Shipments: Imported goods brought into the U.S. for personal use.
For more detailed information, visit the Importing Medical Devices During the COVID-19 Pandemic webpage.
For assistance with import procedures regarding respirators, face masks, test kits, or other medical devices during the COVID-19 public health emergency email: