The proven path for Global UDI Database (GUDID) submission
Meet the FDA's UDI rule and deliver the accurate product data your trading partners require—all through a single pathway
Creating, transmitting, and tracking your GUDID submission data to meet the U.S. Food and Drug Administration’s (FDA’s) new UDI rule—that’s your immediate need, and GHX, in partnership with PTC, can get you there. Our UDI Submission solution helps you meet the FDA requirements and rounds out the GHX Global Data Solutions set, allowing you to submit your data through a single pathway that drives all your critical data feeds to regulators, healthcare providers, distributors and group purchasing organizations (GPOs).The value of this consolidated approach is detailed in the info-graphic at left.
Product data synchronization - simplified
As a medical device manufacturer, you're required to meet the FDA UDI deadline. But in addition to submitting standardized product data to GUDID, you need to synchronize product data with customers and business partners and prepare for future global regulatory requirements.
With the complete GHX UDI solution you can:
- Meet FDA GUDID submission requirements leveraging the PTC UDI solution, which generates the required Health Level 7 (HL7) Structured Product Labeling (SPL)-formatted submission data, transmits it to the FDA’s GUDID, and tracks FDA responses back to each submission.
- Leverage both submission-only technology and data staging technology providing unique data management and synchronization capabilities to automatically keep GUDID submissions current as product attributes change, one of the key requirements of the FDA UDI rule.
- Access expert guidance through GHX business solutions to help you organize internal teams, processes, and data governance to create a sustainable UDI compliance program and achieve additional value through better regulatory data management. See UDI / Global Readiness brochure at right.
- Prepare your data and processes for future UDI regulatory and market requirements worldwide
GHX and PTC: Proven track records in healthcare regulatory and market compliance
- Operates the largest product data repository in healthcare, synchronizing product data across all supply chain participants (suppliers, providers, GPOs and distributors)
- Offers the only GDSN-certified data pool focused solely on the healthcare industry, the GHX Health ConneXion Data Pool
- Since 2000, has continuously collaborated with healthcare business partners and regulatory groups working on global data standards in healthcare, and specifically with the GUDID for the past five years
- Has been an integral part of the FDA’s efforts to develop and test the GUDID, having assisted with the 2009 pilots to test the usability and feasibility of the prototype UDI database and with the 2013 GUDID user acceptance tests
- Offers a full-suite of solutions for Product Lifecycle Management (PLM), Quality Management System (QMS), Reliability and Risk Management, CAD, Service Lifecycle Management (SLM), and Application Lifecycle Management (ALM), which are employed by some of the world’s largest medical device manufacturers
- Has worked alongside the FDA and industry-leading medical device manufacturers over the past three years to develop the PTC UDI Solution
- 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
- Has conducted hundreds of successful test submissions to the FDA’s pre-production GUDID