The US Food & Drug Administration has been working for several years to replace their legacy import system (OASIS) with a more intelligent, risk-based application which will benefit both FDA and the trade. The new system actually consists of three systems:
- Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) allows FDA to use risk-based algorithms when targeting import shipments for inspection of the documents and/or cargo. It also automates the lookup function on their side to the various Centers’ databases to validate that Affirmation of Compliance numbers are valid which should speed up the review and approval process.
- Import Trade Auxiliary Communications Systems (ITACS) allows importers or “anyone that knows the entry number” to submit their documents electronically to the FDA, check on the current status of their entry, and notify the FDA of the preferred exam site. ITACS can be found here.
- Mission Accomplishments and Regulatory Compliance Servers (MARCS) allows FDA to view documents and exam information sent to them via ITACS.
To learn more about these programs, you can view the agency’s FAQs.
For those direct filing with the CustomsNow system, these changes do not require any updates to our application or the way in which you declare entries to FDA. Rather, they are stand-alone applications which augment the ABI data feeds to and from the FDA.
We encourage you to contact the FDA offices with which you work to determine if they are operational on these systems so that you can take advantage of this enhanced process.