Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        FDA Import Process

Entry Submission

                        
                Transmitting Required Information
          Affirmation of Compliance Codes


                Common Entry Submission Errors Home
          For Industry
          Import Program – Food and Drug Administration (FDA)
          FDA Import Process
          Entry SubmissionFDA Import Process Entry Submission
  	
        Share
    Post
    Linkedin

    Email
    PrintProducts regulated by the FDA are subject to review by the FDA when they are offered for entry into the U.S. The FDA electronically reviews all FDA-regulated entries submitted through the U.S. Customs and Border Protection (CBP). FDA-regulated products imported into the U.S. must comply with all of the FDA's laws and regulations. The importer is responsible for making sure these products comply with all U.S. requirements. Products which do not comply with U.S. requirements at the time of importation are subject to refusal of admission.  Below you will find additional information about the submission process for FDA-regulated products.

How do I submit entries of FDA-regulated products?
	What if there is no FD flag associated with my HTS code, but I believe the imported product is FDA-regulated?
	What can a customs broker (entry filer) assist you with during the entry submission process?
	How can I expedite the FDA’s review of my entry?**How do I submit entries of FDA-regulated products?**

The first step in any importation process begins with CBP. You must comply with CBP rules, requirements, and processes. Information about the importation process with CBP can be found at CBP’s website.

To import products into the U.S., you can contract the services of a customs broker (entry filer).  Customs brokers are the only persons authorized by the tariff laws of the U.S. to act as agents for importers in the transaction of their customs business. Customs brokers are private individuals or firms licensed by CBP to prepare and file the necessary customs entries, arrange for the payment of duties, take steps to effect the release of the goods in CBP custody, and otherwise represent their principals in customs matters.

CBP’s website has a clickable U.S. map that will provide a list of specific ports, and under each port, you will find a list of customs brokers. Customs brokers are trained and licensed to facilitate the importation of goods into the U.S. under applicable U.S. laws for importers.

When entry is made with CBP, importers or their customs brokers (entry filer) will include the Harmonized Tariff Schedule (HTS) code among the other declarations in the entry. The HTS codes are flagged with indicators to help guide whether the FDA data is or is not required. The following table displays a list of the FD flags and some examples:

**FD Flag**
			**Is it regulated?**
			**Example**FD1
			May or may not be regulated by the FDA:  If regulated by the FDA, submit entry information; if not regulated by the FDA, disclaim
			Certain chemicals used in manufacturing drug products vs. industrial use; safety goggles for medical use vs. non-medical useFD2
			Regulated by the FDA, but is not food:  Submit entry information
			Medical Devices, Drugs, Tobacco, and CosmeticsFD3
			May or may not be a food product:  If yes, submit Prior Notice (PN) and entry information; if no, disclaim
			Salt used for flavoring food vs salt used for treating road surfacesFD4
			Food product: Submit PN and entry information
			Fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients.

When the HTS code indicates that the product is FDA-regulated, submission of information to the FDA is required:

Electronic submissions: 
	Customs brokers (entry filers) using the electronic system will be prompted to provide the following informationfor the FDA (in addition to the electronic information provided to CBP):

	Commodity and subtype
		Product code
		Product description
		Country code identifying where the product was produced, sourced, grown, or harvested
		Names and addresses of manufacturer, shipper, importer, delivered to party. You can use the FEI portal to look up a FDA Establishment Identifier (FEI) based on a firm name and address or to validate an address of an FEI.
		Contact information
		Estimated arrival date and time (the entry will not be transmitted to the FDA for review until 5 days before the arrival date)
		FDA Affirmation of Compliance (mandatory in some instances)
		Quantity and value (voluntary submission)
		Additional data elements may apply for certain products.  Refer to FDA's Supplemental Guidefor further instruction.Manual (paper) submissions:
	Importers/customs brokers (entry filers) who do not use the electronic system will be directed to provide their entry documentation to the local FDA Import office for review.Regardless of whether the entry information is submitted to the FDA via the electronic system or via a manual process, the FDA will use the information available to determine the admissibility of the articles offered for import.

Back to top

**What if there is no FD flag associated with my HTS code, but I believe the imported product is FDA-regulated?**

Not all HTS codes have FD flags. This does not mean that the product is not FDA-regulated. Based on the intended use of the product, customs brokers (entry filers) are expected to transmit FDA data for HTS codes that do not have an FD flag.

Back to top

**What can a customs broker (entry filer) assist you with during the entry submission process?**

Determine if your product is FDA-regulated.
	Determine appropriate Harmonized Tariff Schedule (HTS) codes, which are required by CBP.
	Inform the importer of FDA-required information and associated affirmations of compliance.
	Obtain a bond sufficient to cover the entry.
	Provide required documentation to FDA, such as government forms, invoices, and certifications.
	*The importer may need to provide these documents to the entry filer.
	Transmit required FDA entry information, using Automated Broker Interface (ABI), through CBP’s electronic import processing system to FDA’s electronic import processing system.
	Enter a product’s affirmation of compliance  information to expedite FDA review.  The importer will need to provide affirmation of compliance information, such as registration numbers, to the entry filer.
	Provide initial or required documents to the FDA through FDA’s ITACS system or other means.
	Electronically file Prior Notice.For information regarding the FDA's entry review process after your entry is submitted, please visit the entry review page.

Back to top

**How can I expedite the FDA’s review of my entry?**

The best way for the FDA to receive notification is through its electronic import entry review system.  Entries processed through this system will be electronically screened against criteria developed by the FDA.

Submitting accurate and complete information at the time of entry, and responding in a timely manner to requests for additional documents/information, helps expedite the entry review process.  Note: Submitting inaccurate or incomplete information may delay the review of your entry.

Back to top

                                                                                  Content current as of:
      06/22/2021Entry Submission                
                          

                        Transmitting Required Information
          Affirmation of Compliance Codes


                        Common Entry Submission Errors
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop