The United States Food and Drug Administration now requires medical devices distributed in the U.S. to bear a Unique Device Identifier (UDI) in human- and machine-readable form. The purposes of this new UDI system are to provide a standardized method for identifying medical devices that is compatible across all health care information sources and systems – making it possible to rapidly and definitively identify those devices and key attributes that affect their safe and effective use. Once fully adopted, the UDI systems expected outcomes are to enable better monitoring and evaluation of in-use devices, improvements in patient safety, and innovation in the designs for the next generation of medical devices.
How can CI Medical help with U.S. FDA UDI requirements?
CI Medical can help your company address U.S. FDA UDI requirements with proven expertise in medical device identification and barcoding standards. CI Medical has the capability to print on most devices and substrates using medical grade inks and processes. In addition to unique devices identifiers, we can also print logos, part numbers, lot numbers, etc., of any size and shape – in formats that are readable by both humans, as well as automatic identification and data capture (AIDC) technology.
For help with adding FDA-compliant UDI markings to your medical devices, contact CI Medical today.