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
For the latest COVID-19 Information from the FDA, please visit this page: Coronavirus Disease 2019 (COVID-19)
COVID-19 Information About FDA Regulated Products
Learn more about how FDA is facilitating the development and availability of medical countermeasures and protecting the public health.
- Animal & Veterinary
- Human Drugs
- Human Food
- Medical Devices
Filing Your Shipment
Please refer to the following information to assist with filing your shipment with the FDA:
- Entry Submission Process
- FDA Import Process
- Importing FDA-Regulated Products: The Import Process (video)
- FDA Supplemental Guide for ACE
- Contains information about data elements required for filing in the Automated Commercial Environment (ACE) for brokers/filers.
Checking FDA Status of Shipment
To check the status of your shipment of COVID-19 products, please query the Customs entry number in our Import Trade Auxiliary Communications Systems (ITACS) portal. You will need to obtain the Customs entry number from your broker/filer.
For further assistance with your shipment, use this interactive map to find the contact information: FDA Import Offices and Ports of Entry
For assistance with import procedures regarding for FDA-regulated products during the COVID-19 public health emergency, please email:
- CSMS # 56244578 - FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic
- CSMS #48653470 - Food and Drug Administration (FDA) Revoking Emergency Use Authorizations (EUAs): Non-NIOSH Respirators, Decontamination/Bioburden Reduction Systems
- CSMS #42635055 - FDA Document Submission During COVID-19 Pandemic