FDA Announces New System Speeds FDA Import Decisions

Posted by Sarah Lilly on 8/8/17 4:37 PM

On July 31, 2017 the Import Director for the U.S. Food and Drug Administration (FDA) issued a blog post analyzing data regarding processing times and admissibility decisions for FDA entries in the Automated Commercial Environment (ACE).

According to the post the below benefits have been made since the transition to ACE:

  • The number of shipments receiving a “May Proceed” without manual review has increased from 26% to 62%
  • The number of lines requiring additional documentation has reduced by 28,374
  • The average time to process an entry with a “May Proceed” is within 1 minute and 36 seconds
  • Manually processed shipments are also being processed with 1 hour, when no additional documentation is required.
  • Manually processed shipments that require additional documentation are being processed within 72 hours, compared to the previous system, which had an average of 96 hours.

FDA also advises that to help decrease the amount of errors, to verify that all correct information is being submitted when initially filed.

The post from the FDA Import Director can be accessed at:

https://blogs.fda.gov/fdavoice/index.php/2017/07/new-system-speeds-fda-import-decisions/

Topics: ACE, FDA

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