HIDA Government Affairs Update
Linda Rouse O’Neill
By Linda Rouse O’Neill, Vice President, Government Affairs
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.
GUDID changes
The 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 page.
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.