FDA entry reviewers are trained to verify compliance with applicable product requirements using the information provided to FDA in the importer’s entry transmission such as:
- Declared Manufacturer
- Declared Importer/Consignee
- Product Description
- Affirmations of Compliance (A of C)
These entry declarations are compared to information in FDA’s internal data systems. FDA uses the internal data systems to verify registration, listing, device approval (when required) or other product requirements and to determine if the firm is subject to DWPE. If the information submitted matches, then compliance is verified; if the information submitted 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 will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDAs internal data systems.
