All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products.  The FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA Import Process

FDA-regulated products imported into the U.S. must comply with the same FDA laws and regulations that apply to domestic products. Entries are submitted to U.S. Customs and Border Protection (CBP) which then refers entries of FDA regulated products to FDA for review.

• Products considered higher-risk and entry submissions with incomplete or inaccurate information are flagged for manual review by FDA to determine the admissibility of the product.
• FDA’s screening tool uses various sources of information to assess risk; for example, a firm’s previous compliance history or known compliance problems with a certain product.
• FDA’s entry reviewers use various sources of information to determine admissibility; for example, using FDA’s registration database to verify whether a declared manufacturer of a drug or medical device product complies with facility registration requirements.
• FDA entry reviewers look for complete and accurate data in the entry submissions. Providing FDA with complete and accurate data expedites the review of your entry.
• Imported items should not be distributed into commerce until FDA has determined admissibility.