Every year, the UDI conference offers guidance and training to those
impacted by unique device identifier (UDI) regulations. The Food and
Drug Administration (FDA) has made several important changes in recent
years, and to help manufacturers, distributors, and group purchasing
organizations, HIDA shared its expertise with participants.
This year’s conference was especially pertinent, as the compliance
deadline for certain class II devices is September 24 of this year. The
deadline had originally been September 24, 2016, but the FDA extended
this deadline to give the supply chain more time to ensure compliance.
most important changes discussed at the UDI conference were this year’s
updates to the FDA’s Global Unique Device Identification Database
(GUDID). Here are the key highlights:
- A number of new data elements have been added to the GUDID download
files. These include the device’s premarket submission number, the
labeler DUNS number, and the public device record key.
- The GUDID release scheduled for the end of summer will include the
premarket submission number and supplement number data. Device labelers
must make sure their GUDID records include all relevant listing numbers.
- Ahead of the summer GUDID release, labelers also need to make sure
they review (and update, if necessary) the confidentiality designations
they have assigned to their device listing records.
As always, if you would like more information, or have any questions, feel free to contact us at HIDAGovAffairs@HIDA.org.
Forthcoming HIDA resource
HIDA will release a new white paper later this summer to assist
manufacturers and distributors in staying UDI compliant while developing
and distributing product through LUM programs. This new resource builds
on our previously-released best practices to provide tangible insights
for trading partners to work together on compliance in LUM programs.
As we have discussed in earlier articles, LUM and JIT programs can
create compliance headaches for distributors and their trading partners.
With the new best practices outlined in this forthcoming resource,
distributors and manufacturers can make sure they are all on the same
For more information on upcoming deadlines, resources, or for ways
you can get involved and learn more about UDI, please contact us at HIDAGovAffairs@HIDA.org.