HIDA Government Affairs Update
By Linda Rouse O’Neill, Vice President, Government Affairs, HIDA
Linda Rouse O’Neill
As a result of HIDA member advocacy with the FDA, including more than 100 Capitol Hill meetings at HIDA’s June Washington Summit, the FDA issued guidance in September extending the compliance date to September 24, 2018, for UDI labeling and Global Unique Device Identification Database (GUDID) submission requirements for certain Class II devices.
HIDA and its members communicated to the FDA that the complex issues in the healthcare supply chain, such as kitting, private labeling, and other practices, create challenges in determining how to comply with the law. This extension allows medical device manufacturers, distributors, and the agency additional time to collaborate and work toward finding solutions that meet the intent of the FDA’s UDI regulation.
Your customers and supply chain customers will likely have questions about UDI rules and the extension. Based on our conversations with the FDA and our members, we wanted to share some insights and answers that can help inform your customer discussions and address concerns your trading partners may have.
To which devices does the compliance extension apply?
- “Collections of two or more different Class II, or Class II and Class I devices packaged together, in which the devices in the package are not individually labeled with a UDI” (in other words, convenience kits)
- “Repackaged Class II single-use devices that are not individually labeled with a UDI”
What does this mean for the supply chain?
This decision extends for two years (September 24, 2018) the compliance deadline for supply chain partners with medical convenience kitting operations that do not contain Class III, implantable, life-sustaining, or life-supporting devices. This means that such products are not required to bear a UDI or have information entered into the GUDID at this time.
The Class II compliance deadline extension also provides supply chain partners additional time to work through the issue of repackaging single-use devices. This specifically applies to the breaking down of single-use devices to the “each” or unit of use level for the purposes of distributor low unit of measure (LUM) and just in time (JIT) programs. It also applies to “breaking down” to the “each” level for medical convenience kitting operations.
The FDA has indicated that it may consider LUM/JIT processes “repackaging” for purposes of the UDI rule. The two-year extension provides the FDA, manufacturers, and distributors additional time to continue its work on this issue and develop best practices for these programs.
What will your company need to do prepare for the new 2018 deadline?
- Continue implementation progress to ensure convenience kits will be compliant with the 2018 deadline and account for Class I and Class II devices.
- Continue conversations with trading partners on LUM and JIT programs.
- Engage with HIDA to inform discussions with other associations and the FDA on the role of distribution in LUM and JIT programs.
FDA willing to work with the industry
As mentioned above, the Class II compliance deadline extension comes on the heels of multiple productive discussions between the FDA, HIDA Government Affairs, and our members. Collectively, we have a great opportunity to collaborate with trading partners and the FDA on implementation. The key now is to take action – whether it is working with your trading partners or sharing your regulatory concerns with HIDA. As always, we will continue to work with our members to raise their concerns with regulators and lawmakers.
We’ll be sure to keep you up-to-date on any factors influencing the medical supply chain. If you have any questions, or want more information on this extension, contact us at HIDAGovAffairs@HIDA.org and we’ll be sure to help.