How entry review works

FDA receives entry data electronically from Customs and Border Protection and screens it against registration, listing and clearance records. Entries that match proceed. Entries that raise a question are flagged as may proceed with comment, held for further review, or referred for examination. Each outcome has a different response path and a different clock.

The four most common hold reasons

• Registration or listing mismatch: the establishment number on the entry does not match an active registration, or the device is not listed under that product code.
• Product code or classification error: the code on the entry does not correspond to the device described on the invoice.
• Labeling deficiency: missing manufacturer or distributor information, missing UDI, or claims that do not match the cleared indication.
• Missing U.S. Agent or importer identification: no designated domestic contact, or an importer of record inconsistent with the entry.

What a good response looks like

A response should answer the specific question asked, attach the record that proves it, and correct the underlying entry if needed. Sending a general letter about the quality of the device rarely helps; sending the listing confirmation that matches the product code usually ends the hold. Where a correction is impossible, reconditioning, re-export or destruction may be the remaining paths, and each requires its own documentation.

Preventing the next hold

Keep the entry package assembled from the same source of truth as your registration record, and re-verify it before each shipment where anything has changed: a new product code, a new label revision, a revised clearance, a new distributor. Most repeat holds are not new problems; they are the previous problem still present in a template.