FDA’s Import and Export Requirements

The FDA and U.S. Customs and Border Protection (CBP) now require the use electronic data submission and strict accuracy requirements. The FDA’s data programs interact in real time.  When and how you manage your computer programs makes a significant difference in the success of your import operations and net profits. When you get into trouble, you must know what to do. Time is not on your side and the FDA’s decision cannot be appealed. 

FDA’s import and export programs are complex, detailed and undergo changes without notice to the public. The FDA’s and CBP’s import program and enforcement process operate with remarkably efficient software systems that can leave a firm scrambling for a resolution and end up suffering the expensive consequences of a detention. The information database used by the FDA includes extensive information from foreign suppliers. If that is not in order, your shipment will not be permitted entry, in some cases even before the products can be loaded onto the vessel in a foreign port or before it arrives at the U.S. port.

Fortunately, exporting products is much easier. The basic criteria for legally exporting products present relatively few problems, except for one that prevents dumping products abroad.  The good news is that you can export products not yet authorized for marketing in the U.S., provided you are in substantial compliance with the applicable Good Manufacturing Practices.

Attend this information-packed session by industry expert Casper E. Uldriks to master FDA and CBP compliance, ensuring your import and export operations run smoothly. Learn to avoid costly delays, navigate complex regulations, and seize export opportunities. Gain crucial insights to protect your business from detentions and refusals. Stay competitive and compliant in today's global market.

Webinar Objectives

• FDA’s legal authority and evidence threshold
• Information required by FDA, CBP and the U.S. Census Bureau
• FDA’s entry evaluation procedures
• Export requirements

Webinar Agenda

• Statutory authority
• Integrated operations with the U.S. Customs and Border Patrol (CBP)
• Information requirements for the FDA and U.S. Customs and Border Patrol (CBP)
• When to submit information
• Managing Import Detentions and Refusals
• Export requirements for product not legally marketed in the U.S.

Webinar Highlights

• Four basic information requirements
• Starting the import information process
• Product identification problems
• What happens when your product is detained.
• Export criteria for products not legally marketed in U.S.
• The “import-for-export” program for “further processing only”

Who Should Attend

• Business Planning Executives
• Regulatory Directors
• In-house Legal Counsel and Contract Specialists
• Venture Capitalists
• Business acquisition Managers
• Owners of New or Developing Import/Export Firms
• International Trade and Logistics Managers
• Import Brokers
• Investors
• Sales Managers