NEW Draft Guidance on UDI
The US Food and Drug Administration released a draft guidance document on Unique Device Identification of medical devices.
The UDI Rule is intended to create a standardized identification system for medical devices used in the United States that makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. Establishing standardized, uniform identification of most devices through distribution to the point of use is intended to reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.