Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained.
Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
The logistics of importing products complicates the process further and you must know the consequences of your decisions. Some problems can cost you time and money, especially when you do not work promptly with the FDA. If you end up with having your entry "refused." There is no appeal. Then you face the possibility of additional steep fines by CBP and be blocked from the U.S. market.
Why you should attend
Firms typically run aground with importing FDA regulated products because they do not understand how to prepare, conduct and report information in accord with FDA requirements. That mire of activity starts before you even ship a product to the U.S. If the exporter and importer do not follow the procedures or fail to submit correct information, the road forward has an expensive and time-consuming toll.
A failure to do things correctly will create a "bad actor" image, which is very hard to undo and FDA does not forget, somewhat like a regulatory elephant. It is true. If you understand the FDA's and CBP's import program, your business can operate in a competitive way. If you do not, your customers, foreign suppliers, and stockholders will see the consequences and not be forgiving.
Agenda
- FDA's legal authority and burden of proof
- FDA registration, product information and the software PREDICT screening program
- CBP entry information and the Automated Commercial Environment (ACE) program
- Tariffs, fees, bonded warehouses, and free trade zones (FTZ)
- Special labelling requirements, e.g., bulk active pharmaceuticals, research use, investigational use, and return for repair
- FDA "holds," "detentions" and what to do immediately
- Negotiating with the FDA
Speakers
Mr Casper (Cap) Uldriks,
Former Associate Center Director ,
FDA's CDRHThrough his firm “Encore Insight LLC,” Casper brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Who Should Attend
- Regulatory Affairs Directors
- Software Designers / Specification Developers
- Production Managers
- Quality Assurance Directors
- In-house Legal Counsel
