UDI Compliance without Complexity
The FDA's new UDI regulation places a significant burden on medical device firms to mine vast stores of product data for the information required to prepare and electronically file UDI-compliant submissions.
Learn how the PTC UDI solution dramatically reduces the complexity and cost of compliance.
In order to improve patient safety, the FDA created a new regulation requiring the standard identification of every medical device throughout its lifecycle. To meet this newly published regulation for UDI (Unique Device Identification), medical device manufacturers must label every product, product version, and product configuration with a unique, 14-digit identifier. What's more, a wide range of critical device information is required to be submitted to the FDA's new GUDID (Global Unique Device Identifier Database) to more effectively track adverse events and safety issues to specific products. Not complying with this regulation would bar device sales across state lines for Class III devices starting on September 24, 2014, which means that noncompliance is not an option for manufacturers selling medical devices in the US.
Working with the FDA and major medical device manufacturers, PTC has developed an efficient, cost-effective solution to help companies manage UDI submissions and gain compliance, while ensuring scalability to meet future FDA or worldwide requirements for UDI.
The PTC UDI solution offers the fastest and lowest-risk way to meet the end-to-end GUDID submission requirements of the FDA UDI regulation. Suitable for any sized company – from ten products to tens of thousands of products – PTC UDI provides the 21 CFR Part 11-compliant technologies required by FDA UDI, and includes pre-built training to help you stay compliant with 21 CFR Part 820.
PTC UDI offers two ways to help companies with Class III devices gain compliance in time for the September 24, 2014 deadline:
- A comprehensive, submission-only solution providing for the transformation, communication, monitoring and reporting of UDI submissions to the GUDID
- An end-to-end, complete UDI data management and submission solution offering a purpose-built regulatory data model for the centralized storage, management, and submission of UDI data from across the organization
The complete PTC UDI solution automatically communicates and tracks UDI data exchanged with the FDA; governs the UDI submission process by providing OOTB compliance with technology and training standards; and manages and synchronizes UDI regulatory information gathered from upstream data store(s) to keep submissions current as products change. It uses FDA algorithms to validate pre-submission data, and it provides for the complete management and traceability of UDI data while retaining the flexibility needed to scale to future regulatory requirements and product changes.
PTC UDI Solution:
- Communicates and Tracks UDI requirements, providing automatic data formatting and submission, FDA response monitoring for quick correction, and enterprise-wide compliance reporting
- Governs the UDI submission process by supporting 21 CFR Parts 11 and 820 with secure electronic records, technology validation, and fully documented training, all within a scalable software architecture to meet emerging global UDI requirements
- Manage and Synchronize changes to keep UDI submissions current with product updates, offering capabilities to collect and control UDI data from across the organization with OOTB templates, preconfigured workflows, and change/configuration management
The PTC UDI solution combines OOTB technology, services, and training to offer an end-to-end solution for managing UDI submissions. Find out more by contacting a PTC representative today.