The Food and Drug Administration Amendments Act of 2007 set forth a new requirement for designation of a unique device identifier (UDI) for all medical devices in the United States. Upon publishing of the final rule in September 24, 2013, all medical device manufacturers and those subject to the rule (i.e. the device “labeler”) had one year to comply with the ruling for class III devices and packaging. The UDI for the devices must meet certain formatting criteria. Submission of device data elements and the device identifiers (DI) to the Global Unique Device Identification Database (GUDID) is also required. There are two methods for submittal: manual entry submission to the GUDID website or Health Level 7 (HL7) Structured Product Labeling (SPL) submission by way of the FDA Electronic Submissions Gateway (ESG). Performance Validation had the opportunity to partner with a leading medical device manufacturer on the requirements and validation of an electronic solution to perform HL7 SPL submissions to the FDA.
TrackWise® was the chosen software solution for this project. With it, configuration of a business process workflow allowed for submission approvals to the GUDID. Data fields, based on the data elements required for submittal to the GUDID and other business process requirements were created as well. The data from these fields was imported from another upstream business process system. TrackWise® submits the device identification data to the GUDID through the ESG and provides submittal success and fail notification to the upstream business process system.
The requirements development required extensive data element analysis and interpretation of the GUDID Guidance for Industry and Food and Drug Administration Staff document and requirements of HL7 SPL submission. Performance Validation team members assisted in these efforts, including the identification of data dependencies, data fields, and selection values. A comprehensive system requirements and data field mapping document was created from these efforts allowing for accurate system development and assurance of FDA compliance.
Given the system interfaces involved, extensive data integration and end-to-end testing was required. Performance Validation tested all success and failure scenarios between the upstream business process system and between TrackWise® and the GUDID. In addition, validation included FDA required test submission scenarios which Performance Validation conducted. Data element integrity and dependencies were tested to validate possible combinations of device information and GUDID field requirements. Along with the critical aspects of data integration and GUDID submission, validation of the TrackWise® workflow and web service configuration occurred.
The Results and Benefits
The UDI submission tool now allows for the medical device manufacturer to easily and quickly submit device information to the FDA GUDID. It meets their business process needs and the FDA regulations. With the experience and skills required for the project, Performance Validation validated the system according to the client’s intended use and FDA regulations. The Performance Validation team integrated with the development team and complied with the organization’s internal procedures as well as utilized their test script writing and execution software (HP Quality Center). Per industry standards, implementation of a risk based approach to validation testing ensured resources focus more time on business process and regulatory criticalities and less on non-critical system aspects. Performance Validation’s involvement with the requirements development process and a clear understanding of the business and regulatory needs facilitated success of the approach. This combination and the above solution provided the client with a successful and efficient implementation.
For more information please contact:
Senior Validation Engineer
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile