The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand the FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.
FDA and the Customs & Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused.
As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense.
Other factors can derail the expectation of a seamless import entry process.
Why You Should Attend
What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.
The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.
When products are refused, you have different options. Some options may cost more than others. For example, your product can be seized and destroyed by the government. You may be fined if you do not act in a timely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.
Learn how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.
On a positive note, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates, for a modest fee, which may give you a competitive advantage in foreign markets. In some cases, an FDA export certificate is required by foreign governments. Finally, the new EU Medical Device Regulation will change how the FDA manages foreign inspections and in your favor.
Day 1 Schedule
FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
Lecture 2: FDA Import Process (continued)
Prior Notice Information
CBP and FDA computer programs
Bonds and Bonded Warehouses
FDA 'Notice of Action'
Import Delays Import Alerts Detention Refusals
Day 2 Schedule
Foreign Inspections FDA 483 - Inspectional Observations
FDA Warning Letters and Automatic detention
Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
Lecture 4: FDA Export Program Special Import Issues