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.