While UDI labeling requirements will be phased in through 2020, all labels and packages of Class II medical devices must have UDI barcodes starting Sep. 24.

How UDI is Improving Medical Devices The safety and reliability of medical devices is paramount. However, there are times that issues arise, causing safety and other potential concerns. To quickly and ...

Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA The FDA originally proposed requiring implantable ...

WASHINGTON (CN) – The Food and Drug Administration has amended its proposal to require unique device identifier (UDI) information on a variety of medical devices, to accelerate the implementation date ...

Loftware Spectrum for Medical Device Purpose Built to Enable Compliance for UDI, EU MDR and 21 CFR Part 11 PORTSMOUTH, New Hampshire, May 22, 2019 /PRNewswire/ -- Loftware, Inc., the global ...

As background, the UDI final rule, published on September 24, 2013, requires that a medical device label and package include an individual UDI, unless an exception or alternative applies.

But FDA UDI will present new challenges for medical device firms too. It’s more than just a label on a package: it requires the collection, transformation, electronic submission, and management ...

"Mr. UDI" gave industry advice on complying with the complex unique device identification rules as medical device companies barrel toward the Sept. 24 UDI deadline for high-risk devices.

QPharma’s Medical Device Division Offers Guidance on UDI Final Rule QPharmaBrendan Middleton, 973-656-0011, Ex. 2112Director of Marketing and Public Relations ...

PORTSMOUTH, New Hampshire, May 22, 2019 /PRNewswire/ -- Loftware, Inc., the global leader in Enterprise Labeling and Artwork Management Solutions, today announced the availability of Loftware ...