Jennifer Diaz was pleased to be back for her fourth year teaching at FIME, rated the #1 medical show in the USA by Successful Meetings Magazine. FIME was held from August 6-8, 2014 at the Miami Beach Convention Center.
This year, Jennifer presented two seminars, both on August 6, 2014. The two topics
• “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”
• “Streamlining the Process – How to Expedite Clearance of Your Medical Devices with U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP)”
After attending the seminars, attendees learned how to effectively operate their business with a new understanding of how to effectively resolve the “worst case scenarios” and importantly, learned what compliance is necessary to expedite the clearance of their goods. She also discussed how she handles everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). FDA issues included what to do if you receive a “Notice of FDA Action” stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a “Warning Letter” that could potential state you must stop producing certain medical devices because they are adulterated or misbranded. Effectively resolving CBP issues included the appropriate response when CBP says your goods are under “detention,” will be “seized” and “forfeited” or are included in the ”detention without physical examination” list and how your company can get off the list. Attendees also learned of the appropriate response after receiving a “liquidated damages claim” up to $50,000 from CBP.
FIME brings together the worldwide medical community for the largest and most comprehensive trade show in the United States, and features medical manufacturers from all over the globe. If you can find it in a hospital, surgery center, physician’s office, medical laboratory, or medical supply store, you can find it at FIME.