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Does Your Medical Device Have a Unique Device Identification (UDI)?

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for READ MORE

6/22/17 EVENT – The Making of Global Cities: Can Miami Follow a Bold Strategy?

The Organization of Women in International Trade (OWIT South Florida) is hosting an event you don’t want to miss: The Making of Global Cities: Can Miami Follow a Bold Strategy?

President Trump Outlines New U.S. Policy on Cuba

We’ve been patiently waiting for today’s announcement since President Trump took office on Friday, January 20, 2017. Some have speculated on whether President Trump’s stance on Cuba would further diplomatic relations following the steps of former President Barack Obama, while the majority have opined that Trump’s next steps could reverse some of the changes made READ MORE

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