Importing CBER-Regulated Products into the United States
What is the process for importing into the United States?
Generally, the process of importing into the United States is governed by Customs laws and regulations which are administered by the U.S. Customs and Border Protection (CBP). CBP has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing United States trade laws. All merchandise coming into the United States clears CBP and is subject to duty unless specifically exempted by law. CBP clearance involves a number of steps: entry, inspection, appraisement, classification, and liquidation. Information must be filed with CBP for all goods imported into the United States. This information, presented in an "entry notice," must be filed with CBP by the importer of record. Frequently, a Customs broker files the entry notice on behalf of the importer of record. (The importer of record is the party holding the bond and is responsible for entry. The importer of record may be the broker, consignee, or true owner of the goods.) The person presenting entry information to CBP is known as the "filer." In order that the merchandise may be delivered to the importer or owner while review of the entry is taking place, a monetary bond is obtained. The bond contains a condition for the redelivery of an imported shipment, or any portion of it, upon demand of CBP.
What standards apply to imports that are regulated by the Center for Biologics Evaluation and Research (CBER)?
CBER regulates biological and related products, including blood and blood products (which includes certain kinds of devices), vaccines, allergenics, tissues, and cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with HIV and AIDs. In order to import a CBER-regulated product into the United States, the product must meet FDA’s regulatory requirements. Foreign firms which manufacture products regulated by CBER that are directly or indirectly imported into the United States must comply with applicable FDA requirements before, during, and after importing into the United States. FDA does not recognize regulatory approvals from other countries.
Who directs and coordinates CBER's import program?
The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's import program (See the Resources for You box on the left-hand side for related links). You can send questions pertaining to the importation of CBER-regulated products to CBERImportinquiry@fda.hhs.gov.
What role does FDA play when an FDA-regulated article is offered for import?
If the article being imported falls under FDA's jurisdiction, it is subject to FDA review. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) sets out basic standards and procedures for FDA review of imports under its jurisdiction. Section 801(a) provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements. FDA regulations at 21 CFR 1271.420 set out the basic import standards and procedures for human tissues. As explained in more detail below, FDA and CBP have coordinated their efforts and work together to ensure the smooth processing of FDA-regulated imports.
Importing CBER-Regulated Products: Roles of Other Federal Agencies
The US Customs and Border Protection (CBP), Centers for Disease Control and Prevention (CDC), and the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) may have regulations that may also apply to CBER-regulated products. Use the link below to learn more.
Importing CBER-Regulated Products: FDA Product Codes
The FDA Product Code, a seven character set of letters and numbers, helps FDA classify and review imports. Use the link below to learn more.
Importing CBER-Regulated Products: Entry Review
To learn more about FDA's Entry Review programs for imported products, click on the resource links provided below.
Importing CBER-Regulated Products: Entry Refusals
To learn more about FDA's Entry Refusal programs for imported products, click on the resource links provided below.
Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research
Do you want to import biological specimens (e.g., blood, tissue, DNA) for testing in a clinical laboratory or for basic scientific research? Use the link below to learn more.
Importing CBER-Regulated Products: Compliance and Regulatory Resources
Additional compliance and regulatory resources related to importing CBER-regulated products are provided on the page below.
- Compliance Program Guidance Manual - 7342.007: Imported CBER-Related Products
- Compliance Program Guidance Manual - 7342.007 Addendum: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
- FDA's Regulatory Procedures Manual, Chapter 9 - Import Operations and Actions
- Import and Export Guidance Documents