FDA's New Import Program Concerning International Consequences 2015

The FDA’s is making major changes to its import program. Some changes start this year. They affect all FDA regulated products. You can voluntarily participate and reap cost savings. The FDA has integrated its import program into the Automated Commercial Environment program, but you must understand information-reporting requirements or you will miss the boat, literally. The FDA also offers a new pre-qualification program for food products. Are you ready to apply? Will you be accepted? If you qualify, you may participate in an expedited clearance process that is similar to the TSE-pre-check for air travel or Homeland Security’s Global Entry Program for international travelers. Import requirements and procedures for the FDA are integrated into the U.S. Customs and Boarder Patrol entry process. You need to understand how their integrated programs and legal requirements work. It is surprisingly seamless. When products are detained, the entry becomes a very costly problem. Firms need to know what its options are and how it can resolve a detention. Learning Objectives: FDA’s new cost-saving import programs Understand how U.S. Customs and FDA legal requirements intersect Know how to manage foreign suppliers Understand FDA’s internal procedures Learn how to mitigate and resolve import detentions Who will Benefit: The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign manufacturers, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles. Business Planning Executives Regulatory Managers In-house Legal Counsel and Contract Specialists Venture Capitalist