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 In this section:

                Importing FDA Regulated Products

Importing FDA Regulated Products

                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
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          Importing Medical Devices
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          Import Program – Food and Drug Administration (FDA)
          Importing FDA Regulated Products
          Importing Biologics and CBER Regulated ProductsImporting FDA Regulated Products Importing Biologics and CBER Regulated Products
  
  	
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This page provides an overview of products regulated by the Center for Biologics Evaluation and Research (CBER) and the requirements that FDA verifies/enforces at the time they are imported or offered for import into the United States.

Overview

	What does CBER regulate?
		What is verified at the time of importation for CBER regulated products?
		How does FDA verify compliance with requirements for products regulated by CBER?
	Registration and Listing
	How does FDA verify registration information for CBER regulated products?
		How do I obtain blood establishment registration information?
		How does FDA verify premarket submissions?
		How do I obtain products and establishment information for products regulated by CBER?
	Affirmation of Compliance Codes
	Combination Products
	Importing biological samples for basic scientific research or testing
	Additional Biologics InformationBack to top

**What does CBER regulate?**

Biological products, including blood and blood products, blood derivatives, vaccines, allergenics, gene therapies, cellular therapies, and xenotransplantation.
	Human cells and tissue products (HCT/Ps) that are intended for implantation, transplantation, infusion, or transfer into a human recipient. This may include bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.
	Medical devices involved in the collection, processing, testing, screening, manufacture and administration of blood, blood components, and human tissue and cellular products.
	HIV test kits used to screen donor blood, blood components and tissue and cellular products (HCT/Ps), and products used to diagnose, treat, and monitor persons with HIV and AIDS.
	Certain drug products, including blood bags with anti-coagulant, and plasma volume expander.Visit the Vaccines, Blood and Biologics webpage for more information.

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**What is verified at the time of importation for CBER regulated products?**

At the time of importation, FDA will verify compliance with the following product specific requirements for CBER regulated products:

**CBER Regulated Biological Products**

Biologics License Application (BLA):****This requirement may be met by providing the Submission Tracking Number (STN) and/or a Biologics License Number (BLN).
	Investigational New Drug (IND): This requirement may be met by providing an active IND number.**CBER Regulated Drugs approved under Section 505 of the FD&C Act**

Drug Establishment Registration:****This requirement may be met by providing the drug registration number (REG).
	Drug Approval:****This requirement may be met by providing the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) number.****
	Investigational New Drug (IND):****This requirement may be met by providing an approved IND number.**CBER Regulated Medical Devices**

CBER regulated medical devices must comply with the same requirements as medical devices regulated by the Center for Devices and Radiological health (CDRH). Visit the medical devices page for information on registration and listing requirements. Additionally, CBER regulated medical devices may require one of the following pre-market submissions:

Premarket Notification 510(k) (PMN): This requirement may be met by providing the premarket notification (510(k)) number.
	Premarket Approval (PMA):****This requirement may be met by providing the premarket approval number.
	Investigational Device Exemption (IDE): This requirement may be met by providing the IDE number.If you would like more information about biological devices visit the Devices Regulated by the Center for Biologics Evaluation and Research page.

**Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)**

HCT/P Establishment Registration: This requirement may be met by providing the registration number (HRN).****
	HCT/P Affirmation: This element may be met by affirming compliance with 21 CFR Part 1271 (HCT).For additional information, please visit CBER’s Tissue and Tissue Products page.

If you have further questions you may contact CBER.

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**How does FDA verify compliance with requirements for products regulated by CBER?**

FDA entry reviewers are trained to verify compliance with applicable product requirements. The FDA entry reviewers use the information provided to FDA in the importer’s entry transmission such as:

Declared Manufacturer
	Declared Importer and Consignee
	Product Description
	Country of Production
	FDA Product Code
	Intended Use Code
	Affirmations of Compliance  (A of C)These entry declarations are compared to information in FDA’s internal data systems. If the information matches, then compliance is generally verified; if the information does not match, FDA may gather additional information or may detain the product.

The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment may be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDA internal data systems.

Note: Submitting inaccurate or incomplete information may delay the review of your entry.

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**Registration and Listing**

Establishments that are involved in the production and distribution of blood and blood products, medical devices, biological drug products and HCT/Ps intended for commercial distribution in the United States are required to register and list annually with the FDA.

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**How does FDA verify registration information for CBER regulated products?**

FDA will verify that the declared manufacturer is registered by comparing the submitted information to FDA’s establishment registration database. If required, FDA will also verify the declared importer is registered. If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.

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**How do I obtain blood establishment registration information?**

You may search the blood establishment registration database for registration information for any blood establishment that is registered with FDA.

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**How does FDA verify premarket submissions?**

FDA will verify the declared BLA, PMA, 510(k), IDE, NDA, ANDA, IND, by comparing the submitted information to FDA’s data systems. If the information is not supplied, or is incomplete or inaccurate, it may delay the review of your entry. If the information matches, then compliance is generally verified; if the information does not match, FDA may need to gather additional information or may detain the product.

If the product requires a BLA, PMA, PMN, IDE, NDA, ANDA, or IND and does not have one, it will be subject to refusal.

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**How do I obtain products and establishment information for products regulated by CBER?**

You may visit CBERs Biologics Products & Establishments page for listings of CBER Regulated 510(k) submissions and PMDA Devices, licensed biological products, and CBER regulated NDA and ANDA drugs.

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**Affirmation of Compliance Codes**

Affirmation of Compliance codes  (A of C) are three letter codes plus qualifiers (where applicable) that can be provided at the time of import to facilitate FDA review. Qualifiers provide product and manufacturer specific information FDA can use to verify your product is in compliance.

Providing the correct A of C codes reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process. FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements.  Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.

For information on A of C codes as well as descriptions and examples of CBER regulated product affirmation of compliance codes refer to the “Affirmation Of Compliance References” on the affirmation of compliance codes page.

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**Combination Products**

Combination products are therapeutic and diagnostic products that combine drugs, medical devices, and/or biological products. Based on primary mode of action, a combination product is assigned to a “lead-center” that has primary jurisdiction for its regulation. For more information on combination products, including product jurisdiction and assignment of the lead center, visit the Frequently Asked Questions About Combination Products page.

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**Importing biological specimens for basic scientific research or testing**

If the biological specimens you are offering for import are intended for use only for testing in a clinical laboratory or for basic scientific research and are not articles intended for the prevention, treatment, diagnosis, or cure of diseases, injuries, or conditions in human beings, the specimens are not regulated by FDA. Thus, when submitting the entry notification for such specimens, your broker/entry filer will need to “disclaim” FDA jurisdiction if the CBP HTS code allows. For more information visit the Importing CBER Regulated Products: Clinical Laboratories and Basic Scientific Research page.

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**Additional Biologics Information**

FDA does not regulate the transplantation of vascularized human organs such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs. For more information visit the Tissue and Tissue Products Questions and Answers page.

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Useful Links
	FDA Supplemental Guide
	CBER Common Entry Errors
	Automated Commercial Environment/International Trade Data System (ACE/ITDS)
	7342.007: Imported CBER-Related Products
	7342.007 Addendum: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
	Importing CBER-Regulated Products into the United States
	FDA Product Codes For Importing CBER-Regulated Products
	Importing CBER-Regulated Products: FDA Interactions with other Agencies
	Import and Export Guidance Documents
	Exporting CBER-Regulated Products



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                                                                                  Content current as of:
      02/03/2021Importing FDA Regulated Products

          
                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies
 
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