The Unique Device Identifier (UDI) for medical devices was introduced by the United States Food and Drug Administration (FDA) in 2007 to improve medical device traceability and performance. FDA published the UDI final rule detailing the regulatory requirements in September 2013 and provided further guidance in July 2014. Class III medical devices were required to have UDI compliance in September 2014, and deadlines for Class II and I will be in 2015 and 2018, respectively. It is likely that global adoption of FDA unique device identification, or similar regulatory requirements, will occur. UDI implementation may seem to be yet another “regulatory hoop” that medical device companies must support, however in our view it is an opportunity to improve the patient experience by providing a more holistic approach to launching and tracking medical technologies pre-market and post-market launch.
Follow our 4 key steps for UDI compliance, complete with the challenges you’ll face as well as solutions provided by the Licensed to Cure for Medical Devices industry solution experience powered by the Dassault Systèmes 3DEXPERIENCE© platform.
- Prepare the device identification (DI, see Figures 1 and 2) records by acquiring all the relevant data from various sources and documents. Data for the DI include elements like Device Identifier Type/Code, Make/Model, Brand/Trade Name, and Clinically Relevant Size. The data needs to be validated by departmental stakeholders to ensure that the information represents the final released product for the UDI submission.
Challenges: Data aggregation may be difficult because it is in different forms, and medical device companies need to collect between 70 and 120 different product attributes to meet regulatory requirements. Of these data attributes, 55 DI attributes are submitted to the FDA GUDID.
Solutions: Manage DI records collection as a project, using an enterprise process workflow to assign tasks to different parties to provide information from across your organization.
- Submit and Publish the DI record to the U.S. FDA global unique device identifier database (GUDID). After filling out the FDA forms and submitting to the FDA GUDID, the Regulatory Manager must wait for the acknowledgement of acceptance. If the submission is not accepted, the issues identified are addressed and the DI resubmitted to the FDA GUDID.
Challenges: The UDI labeling process, which is already lengthy due to data aggregation, formatting, and coordination of cross-functional teams, is lengthened further by this process. Waiting for acknowledgement, and the possibility of needing to resubmit, adds to time pressures to meet deadlines and to coordinate with the product launch.
Solutions: Improve project management efficiency by maintaining a “single version of the truth” medical device database. Review and approve DI record using electronic signatures to stay compliant. Receive and record acknowledgement from FDA GUDID when a submission is successful or record rejection notices for invalid DI record submission.
- Maintain and Monitor the device status throughout the product lifecycle to keep the U.S. FDA product registration and GUDID up-to-date.
Challenges: Ensuring total traceability of the UDI implementation.
Solutions: Store all device attributes (based on a pre-formatted data model aligned with U.S. FDA guidelines) in one enterprise medical device database (device information, packaging and secondary information, and device characteristics).
- Bridge Information between medical device reports and DI records to build root cause analysis of data and any issues. The Regulatory Manager needs to associate device/patient issues with identified product to accelerate post-market surveillance activities (for example, adverse event reporting/aggregation, medical device recalls, tracking and tracing, and patient notification).
Challenges: Growth of medical device companies, sometimes through acquisition, make it difficult to track and manage uniformity, accuracy, semantic persistence, stewardship, and accountability of label identifiers, as well as other device data elements needed for regulatory compliance.
Solutions: Increase information sharing throughout the enterprise using a centralized repository of DI records. For root cause analysis, perform “where used” analysis to highlight relationships with other databases, such as complaints (internal/external).
Medical device companies face many challenges in meeting the FDA UDI requirements. Dassault Systèmes has a long history in the Medical Device industry, helping leaders create and launch breakthrough innovations. For Class I, II, and III devices, from small organizations to global enterprises integrated with suppliers, our solutions help companies accelerate innovation to market safely, more quickly, at a lower cost while maintaining quality and reducing regulatory risk.
Listen to a recent webinar featuring former-FDA and UDI regulation author, Jay Crowley and partner Kalypso by clicking here.