This year, I’ll be presenting two seminars, both on August 6, 2014. The two topics are:
- 10:00 a.m. – “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”
- 12:00 p.m. – “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 this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the “worst case scenarios” and importantly, you will learn what compliance is necessary so you can expedite the clearance of your goods. We will discuss how we handle 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 include 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 includes 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. You will also learn the appropriate response after you receive 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.
View the complete seminar schedule for FIME Show 2014 here.
If you want more information about medical device compliance issues with FDA and/or CBP, please contact me anytime at (305) 260-1053 or by email at JDiaz@bplegal.com.