Needham, Massachusetts – PTC officials announce the successful submission of UDI data to the preproduction version of the U.S. Food and Drug Administration's Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA's UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
The FDA's first UDI compliance deadline for high-risk Class III devices is Sept. 24, 2014. High-risk devices are identified as the most complex life-sustaining medical devices like pacemakers, defibrillators, vascular stents, and ventilators. Medical device manufacturers need to implement compliant processes and technology to meet the UDI requirements and avoid any potential negative consequences.
According to Jay Crowley, vice president of UDI practice at USDM Life Sciences, "It's important that device companies have a solution that's fully capable of meeting current FDA GUDID requirements, while also being scalable and flexible for future global UDI requirements. The PTC UDI Solution enables medical device manufacturers to submit the appropriate records to the FDA's GUDID."
PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill platform, the PTC UDI solution is a preconfigured, enterprise software solution designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. The solution is fully validated in accordance with 21 CFR Part 11 requirements and enables manufacturers to gather, submit and track GUDID data.
The PTC UDI Solution enables manufacturers to:
- Communicate and track GUDID submission data, managing the electronic relationship with - including responses from - the FDA's GUDID and tracking submissions across product lines to ensure enterprise-wide compliance.
- Govern GUDID submissions in accordance with FDA regulations, enabling customers to oversee and control the status and progress of all submissions across product lines within a 21 CFR Part 11 compliant solution including software validation, training and electronic data management.
- Manage and synchronize changes to GUDID submissions through robust software architecture to easily manage large sets of similar data as well as ensure that product changes in upstream data stores kick off new or revised GUDID submissions to meet ongoing compliance needs.
"The only real certainty with GUDID compliance is that global requirements will likely change. Continuing compliance will require a practical solution that's fully capable of meeting all current UDI regulations for submission data, and fully scalable to support the many more global UDI requirements anticipated for the future," said Mark Hodges, division general manager, PLM segment, PTC. "The PTC UDI Solution delivers accuracy, scalability, and quick response times for GUDID compliance initiatives."