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Jennifer Diaz Opens Medical Device Seminars at FIME

posted by Jennifer Diaz August 2, 2012 0 comments

Attorney Jen Diaz will be presenting the first seminar "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices" at the FIME Show at 10:00 AM on Wednesday, August 8, 2012 at the Miami Beach Convention Center.  This will be Jen’s third consecutive year teaching at FIME.

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."  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 2012 here.

If you want more information about medical device compliance issues with FDA and/or CBP, please contact Jen Diaz at (305) 260-1053 or by email at JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

FoodMedical Devices

Medical Devices Seminar

posted by Customs & International Trade Law Blog August 6, 2009 0 comments

On August 14, 2009, Jennifer Diaz and I will speak at the annual FIME Conference taking place at the Miami Beach Convention Center, Miami Beach, Florida. The FIME Conference is one of the largest trade shows in the United Stated attended by medical device manufacturers, importers, and distributors from throughout the United States and Latin America.

The seminar topic is “How to Effectively Resolve Typical U.S. Food and Drug Administration and U.S. Customs and Border Protection Issues for Medical Devices.”

Medical devices are strictly regulated by the FDA.  We will discuss how to handle everyday examples of difficult issues with he U.S. Food and Drug Administration (FDA).  FDA issues include what to do if you receive a "Notice of FDA Action" or a "Warning Letter" that could potentially state you must stop producing or importing certain medical devices.  FDA may allege that the device is adulterated because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, the FDA may allege that a device is misbranded because you have not submitted a section 510(k) premarket notification to notify the FDA of your intent to introduce the device into commercial distribution for these new intended uses. Your company may have its imported merchandise authomatically detained by the FDA because it is on the "detention without physical examination" list.  Fortunately, there is a procedure to get off that list.

Effectively resolving U.S. Customs and Border Protection (CBP) issues includes appropriately responding when CBP says your medical devices are under "detention," or will be "seized" and "forfeited".   You will also learn the appropriate response after you receive a "liquidated damages claim" up to $75,000 from CBP.