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        Importing FDA Regulated Products

Importing COVID-19 Supplies Home
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          Import Program – Food and Drug Administration (FDA)
          Importing FDA Regulated Products
          Importing COVID-19 SuppliesImporting FDA Regulated Products Importing COVID-19 Supplies
  	
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    Print**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


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
	Biologics
	Human Drugs
	Human Food
	Medical Devices
	Importing Medical Devices During the COVID-19 Pandemic
		CSMS # 56244578  - FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 PandemicFiling 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:

COVID19FDAImportInquiries@fda.hhs.gov

Related Information
	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

Additional Resources
	Personal Importation
	Importing FDA-Regulated Products
	Product Code Builder
	FEI Portal
	FDA Data Dashboard

                                                                                  Content current as of:
      07/01/2021
                  
                   
Health Topic(s)
			  Infectious Disease
			    			       			    			       CoronavirusImporting COVID-19 Supplies
 
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