CSMS# 17-000077 - Use of UNK In Place of an Intended Use Code for FDA Transmissions
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02/13/2017 04:14 PM EST
Partner Government Agencies
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: ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320
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: ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320
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