January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

A new system that provides unique labels to identify medical devices is being instituted by the U.S. Food and Drug Administration. Called the unique device identification system (UDI), it will ...

Sign up for the On Point newsletter here. Congress recently, and quietly, gave the FDA the power to prohibit off-label uses of medical devices. "I think it’s a move ...