Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...

Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA "Mr. UDI" gave industry advice on complying with the complex ...

Recently, the FDA released a final rule requiring most medical devices sold within the United States carry a unique device identifier (UDI barcode), to be documented and tracked for patient safety ...

Lawrenceville, N.J.-based GS1 Healthcare US has released a guideline to help facilitate the implementation of the U.S. Food and Drug Administration’s Unique Device Identifier Rule that requires ...

Briefly, the rule requires medical device manufacturers to assign a UDI-compliant code to each of its covered products, to label tho~ products with the code in both human and machinereadable (e.g., ...