A coalition including the American Health Assn., the American Nurses Assn. and several specialists’ associations urges Food & Drug Administration chief Dr. Margaret Hamburg to expedite the adoption of ...
The Food and Drug Administration today announced a long-awaited final rule for the unique device identification system intended to provide a consistent way to identify medical devices. The UDI system ...
The Food and Drug Administration issued draft guidance clarifying the form and content of special tracking labels for medical devices. Specifically, unique device identifiers must appear in both plain ...
Medical device manufacturers are among the top innovators in the world, developing life-saving technologies at a pace that frequently outstrips that of other industries. Yet when the stakes are ...
The Food and Drug Administration (FDA) released Tuesday a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI). A UDI is a unique numeric or ...
FDA has finalized guidance on the form and content of unique device identifiers used to track medtech products through the supply chain. The final text responds to, but in some cases holds firm ...
One day before the U.S. Food and Drug Administration’s (FDA) deadline for medical device companies to submit Class III product data to the FDA’s Production Global UDI Database (GUDID), GHX announced ...
LAKE MARY, FL--(Marketwired - March 23, 2015) - Fonon Technologies ("Fonon"), a pioneer in next-generation 3D Fiber and CO2 Material Processing Systems, announces its LaserTower™ family of FDA ...
In an effort to bring clarity to the jargon-laden topic of unique device identification, the FDA released a straightforward, question-and-answer style guidance yesterday that tackles how to understand ...