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.
Listen to PTC's Jill Newberg explain 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 supply chain journey. To meet this newly proposed regulation for UDI (Unique Device Identification), medical device manufactures and their suppliers 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, which means that noncompliance is not an option for medical device manufacturers 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.
- Overview
The PTC UDI Solution is a preconfigured, out-of-the-box offering to help medical device manufacturers meet the end-to-end needs of the UDI submission. The PTC UDI Solution automatically collects and controls UDI data; automates key workflows like review and approval, data verification, and electronic submission; and streamlines critical processes such as response tracking, change management, and submission history. The PTC UDI Solution uses FDA algorithms to validate pre-submission data and provide 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:
- Collects and controls UDI data in a single, easy-to-use system with preconfigured OOTB workflows
- Automates review, formatting, and submission to the FDA; monitors responses and handles exceptions
- Streamlines changes, resubmissions, and reporting while ensuring scalability to meet future requirements