Fast Stats

July 2017

1,440,277

is the number of device records the FDA says the Global Unique Device Identification Database (GUDID) has, as of May 2017 — more than double that of 2016.

4,470

is the number of GUDID ID labeler accounts, an increase from 1200-plus in 2016.

September 24,2020

is the new compliance date for Class 1 devices with Labels. Direct Mark devices are required by September 24, 2022. The same dates apply to Unclassfied devices. The extension is to give manufacturers more time to gather their information on this large class of devices.

15%

is the number of healthcare systems that have adopted UDI/GTIN/GLN; another 32% are working on their plan for adoption.

44%

of healthcare systems said they were not working on UDI adoption.

38%

said the main barrier to UDI adoption is that their EHR/EMR or MMIS systems
don't support the data.

23%

of healthcare systems said the barrier to UDI adoption is that they have no budget for it.

13%

of healthcare systems said their C-Suite wasn't interested or supportive of the
UDI initiative.

Source: UDI Facts from FDA-UDI conference, June 2017, and HPN April 2017 reader survey