Over the last few years, Class III and some Class II devices have been subject to Unique Device Identification (UDI) Rule: US Legislation (FDAAA 07; FDASIA 12). In the next few years, Class II, Class I and Non Sterile Implants will be subject to the same rules. However, unlike Class III and Class II, these remaining groups may not be prepared for the upcoming changes.
The main purpose of the initiative is for better traceability of medical devices throughout the supply chain. The goal is to also improve the information available to manage product quality issues, which could potentially impact patients. In addition, the solution can provide visibility to device recalls, adverse event reporting, serial\lot tracking and tracing, anti-counterfeiting, product shortages and better scanning capabilities.
In order to meet UDI compliance requirements, companies need a solution that can support the two elements of the regulation for each shippable SKU:
- Registration of the UDI "static" device identifier with FDA GUDID.
- Ensure traceability of the UDI "dynamic"production identifier (P.I) attributes by internal company processes.
Here are some steps to ensure readiness:
- Work with an FDA accredited resource to assign and maintain UDIs.
- Establish processes for physical labeling.
- Assign and place a UDI on every device's label. Put the UDI in plain text and as a barcode, making sure to verify the barcode with a specialized barcode verifier. Identify and collect all necessary data for the GUDID.
- Determine submission method. If submitting manually, follow the FDA processes in User Manual. If submitting electronically, establish an FDA ESG account and complete testing (if HL7).
- Submit the UDI data to the GUDID database.
- Update SOPs to document and maintain the UDI process.
Companies will need to assess the impact UDI requirements they have across all the business functions within their organization. Companies should not define their UDI initiative just as a regulatory requirement, but rather as an enterprise wide strategy. Doing this will not only achieve UDI compliance, but will also leverage the UDI foundation for enhanced business value as well.
Do you have questions on how to prepare for the upcoming UDI challenges and changes that your company may face? Contact Tribridge to learn how to best meet these challenges head-on with our expert consulting services and innovative solutions for Health & Life Sciences.