PREDICT Possible Mandatory Affirmation of Compliance Codes

Wednesday, July 28, 2010

FDA: PREDICT and Possible Mandatory Affirmation of Compliance Codes

In a recent webinar presented by the Food and Drug Administration, FDA officials noted that the rollout of PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance) is presently on hold.  PREDICT is the new risk-based screening system for imports that will replace OASIS. 

 

Also, there was discussion regarding the Affirmation of Compliance Codes (AofC) which are codes used to affirm that products subject to FDA’s authority meet FDA requirements and provide information to expedite the review of entries.  AofC codes are currently voluntary, but certain codes may become mandatory in the future. 

 

The webinar will be posted to FDA’s website in the near future.  To find out more about AofC codes and PREDICT you may visit the following websites:  http://www.fda.gov/ForIndustry/ImportProgram/ucm172743.htm

http://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/compliance.pdf