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CSMS #42635055 - FDA Document Submission During COVID-19 Pandemic

The Food and Drug Administration (FDA) continues critical work to protect public health during the COVID-19 pandemic. This work includes review of FDA regulated products offered for importation. If a request for documents is received from FDA, filers and/or importers are strongly encouraged to submit product labeling along with regularly submitted entry documents (commercial invoice, packing list, way bill, etc.). Submission of labeling will help expedite the admissibility process during this pandemic.

Labeling along with entry documents should be submitted electronically via the FDA Import Trade Auxiliary Communication System (ITACS). ITACS functionality can be accessed at https://itacs.fda.gov. This includes checking statuses, providing requested documentation and location of goods electronically, and checking the estimated laboratory analysis completion dates for lines which have been sampled.

Additional information on ITACS, including questions and answers, can be found on FDA’s ITACS for Industry webpage: https://www.fda.gov/industry/import-systems/itacs . For further questions regarding ITACS, please contact itacssupport@fda.hhs.gov.