FDA Review Response Time Frames in ACE

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U.S. Customs and Border Protection Jul 04, 2016

FDA regulated commodities go through multiple screening processes, depending on the product. From the time FDA successfully receives the entry data in its system, the screening process can vary from minutes to same business day processing, or multiple business days depending on the volume of entries/lines sent by CBP at a given time and the quality of information transmitted. At the end of this screening process FDA’s system will return to CBP a message from CBP’s ACE Cargo Release Status Notification Implementation guide, https://www.cbp.gov/document/guidance/cargo-release-status-notification-implementation-guide.

For commodities that require Prior Notice, the Prior Notice Confirmation Number should typically be received within 30 minutes (based on volume of entries/lines received within that window) from the time FDA successfully receives the data in their system.

FDA does not have a regulatory mandate regarding entry review time frames when determining admissibility of the FDA-regulated articles under 801(a.) However, FDA continues to improve the efficiency and consistency of the import admissibility process, including development of internal standards regarding entry review for an initial admissibility determination under 801(a.)

FDA regularly monitors its system and process performance throughout each day for anomalies.