Best PracticesFDA IssuesMedical DevicesSpeaking

Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME

posted by Jennifer Diaz July 29, 2015 0 comments

If you import medical devices into the U.S. (or want to), FIME is the trade show for you. Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair – and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the
largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.  

I’m thrilled to say I’m speaking again this year. My topic is “How to Effectively Resolve Typical U.S.
Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”. 

My seminar will take place on August 5, 2015, at 10:00 am (EST) in Room D232.
To entice you to attend, here’s a snapshot of the agenda:
  • Medical Device Basics
  • FDA Laws/Regulations
  • FDA Import Process
  • What You Need to Know to Import
  • How to Work Best to Expedite Your Shipments with a Customs Broker
  • FDA Notices of Action 
  • FDA Detention and Refusal Process
  • Import Alerts
  • Detention Without Physical Examination
  • Typical U.S.
    Customs Liquidated Damages and Seizure Process
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.  

Check out all of the terrific seminars here
Ready to Register? CLICK HERE, and REGISTER TODAY! 
If you will be at FIME, I am offering FREE consultations, at FIME ONLY. Contact me
at jdiaz@bplegal.com to set up your FREE (no obligation) consultation today!
See you at FIME! 

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