With the final rule for the FDA’s proposed unique device identification (UDI) expected to be released this summer, orthopaedic manufacturers are beginning to focus on what they will need to do to comply with the regulation. Orthopaedic OEMs will be among the first to be impacted, with the final rule expected to require manufacturers of Class III devices to be in compliance one year after it is published. One of their biggest challenges will be about data, but those who take a more holistic approach to UDI have an opportunity to reap potential benefits beyond just checking the regulatory box.
FDA has said the final rule will mirror much of what is in the proposed rule, giving manufacturers a good place to start preparing now (see sidebar), but there are still some critical areas of uncertainty, including:
These are all legitimate concerns, but they should not stop a manufacturer from beginning to think about how it will achieve compliance, and if possible, added value. Global manufacturers should also consider how their compliance efforts in the U.S. will relate to UDI regulations in other parts of the world. The European Commission has already issued draft regulations referencing UDI, as well as a vision for a common UDI framework, and countries ranging from Korea to Canada are considering their next steps around UDI.
When it comes to UDI, manufacturers are encouraged to think globally and holistically to minimize compliance challenges and to leverage those efforts for additional efficiencies across multiple functions and regions.
For more on UDI, including which stakeholders to involve in the preparation process and how to comply:
11 Questions OEMs Should Consider to Prepare for UDI:
1. Which products will be covered by UDI and when?
2. Is production manual or automated?
3. Where are those products produced?
4. Into which markets are they sold?
5. Will the label artwork have enough space to accommodate the UDI?
6. Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor?
7. How will you handle validation of new IT equipment and processes?
8. Do you have kits or combo products? If so, you do label each of them late-stage and then combine?
9. Do you have multipacks? Will secondary or tertiary labeling be required?
10. Do you have any products that are implanted longer than 30 days or that must be re-sterilized before reuse, and may require direct part marking?
11. Will you need to add a contingent workforce to prepare for UDI?