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 UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. […]
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?
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 by the former President. The speculation can now be put to the side as today President Trump delivered a speech in Miami (at the Manuel Artime Theater), a little over 90 miles away from the island of Cuba, outlining his new policy with the communist island. The announced changes do not take effect until the new OFAC regulations are issued. The forthcoming regulations will be prospective and will not affect existing contracts and licenses.
Here is a summary of the MAIN changes, and background of why the President has signed an executive order making these changes in support of the Cuban people:
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, we find many companies unsure if its products are, in fact, medical devices.
The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.
What is a Medical Device? […]