From CSMS #17-000227:
CBP and FDA are in the process of updating the ACE PGA flags for FDA requirements. Specifically, the tariff numbers that had flags for ACS OGA of FD0 are getting ACE PGA requirements updates to have either no FDA flag, FD1 (FDA May Be Required) or FD2 (FDA Required).
In the meantime, following is a spreadsheet of the FDA HTS codes and their associated flags in ACE. Trade can use this as a reference in investigating any rejects they may be getting when filing entries. FD0 flags do not exist in ACE.
If you have questions about the HTS flags please contact FDAImportsInquiry@fda.hhs.gov or Ted.Poplawski@fda.hhs.gov
CBP spreadsheet >> FDA HTS codes and flags