- To : Automated Broker Interface, New ACE Programming, Partner Government Agencies
Subject: Use of UNK In Place of an Intended Use Code for FDA Transmissions
FDA is suspending, until further internal discussion, the implementation of the programming
changes in ACE that would result in a rejection by CBP of an entry for failure to submit the medical device listing number and associated
medical device registration numbers (PG23) when “UNK” is submitted in
place of an Intended Use Code (PG01).
FDA highly encourages the transmission of complete data, including the
correct Intended Use Code and Affirmations of Compliance. Refer to the Supplemental Guide for the full list of requirements based on the various
import scenarios.
UNK should only be used if the correct Intended Use Code cannot be ascertained and needed entry information is not available. Utilizing this code may lead
to manual review by FDA which can cause delay in FDA’s evaluation of the
entry.
For questions, please contact FDA ACE Support: [email protected] or 877-345-1101 or 571-620-7320