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.
Entry Submission Process
Specific information must be provided to FDA when submitting an entry, which may include documentation. Failure to submit this information may delay the review of your entry. For additional information on the entry process, please click on one of the below links:
- Transmitting Required Information
- Affirmation of Compliance Codes
- Harmonized Tariff Schedule and FD Flags
- Documents Required Status
- Entry Review
FDA utilizes various electronic import systems such as ACE/ITDS, ITACS, PREDICT, OASIS and Imports Entry Review application to review and validate entry data and information. Information on FDA's import systems can be found by visiting the import systems page.
Common Entry Submission Errors
Errors in entry submission information may lead to a delay in entry processing. Common errors and tips on how to avoid them can be found on the common entry submission errors page.