For years I’ve heard the terms “FDA-approved,” “FDA-cleared,” and “510-k application,” associated with the review of medical devices at the U.S. FDA, but I wasn’t clear on their definitions. For the T1D Exchange, I dug in to learn more and share with readers just how FDA’s Center for Diagnostics and Radiological Health (CDRH), classifies and reviews medical devices. This article also details how FDA has recently revised several terms and regulations to open the door for innovation in diabetes devices and care. This article is also posted on the Association of Diabetes Care & Education Specialists (ADCES) blog: You can read it here...