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WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

Who knew dental floss was a medical device regulated by the U.S. Food and Drug Administration (FDA)? What about contact lenses, sunglasses, tongue depressors, dental floss, or bedpans? How about pacemakers? You guessed it, they all are! One might naturally think of a product like a defibrillator as a medical device, but in our business, READ MORE

FDA Launches New Webpage to Promote Use of Symbols in Labeling of Medical Device

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later. FDA intends the final rule to be an attempt to “harmonize the U.S. READ MORE

Medical Device Registration Made Easy!

This article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA. FDA’s classes of medical devices: “The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic READ MORE

3 Part Compliance Seminar Series You DON’T Want to Miss!

We are excited to announce our upcoming 3 part seminar series on Importing, Exporting, and FDA Compliance! Government and private speakers will participate.   Each seminar will provide resources for new and experienced international trade professionals including:

Jennifer Diaz Opens Medical Device Seminars at FIME

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 READ MORE