For Industry

CBER Regulated Products

Overview

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.

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What does CBER regulate?

  • Biological products, including blood and blood products, vaccines, allergenics, gene 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

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:

Biological Products

Human Drugs Regulated by CBER

Medical Devices Regulated by CBER

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:

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:

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 510(k) submissions, licensed biological products, NDAs and PMAs.

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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 Samples 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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Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/31/2018
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