PTC has submitted Unique Device Identifier (UDI) data to the U.S. Food and Drug Administration’s Global UDI Database (GUDID). The submission was completed through the Electronic Submission Gateway in HL7 SPL format.
This database, part of the FDA’s UDI rule, seeks to dramatically reduce instances of patient injury and death resulting from misidentification of medical devices, a company press release states. This ruling reinforces that medical device manufacturers need to implement compliant processes and technologies to meet UDI requirements. The first compliance deadline for high-risk Class III devices is September 24. This class includes life-sustaining medical devices such as pacemakers, defibrillators and ventilators.
To assist manufacturers, PTC has developed a preconfigured software solution for GUDID submissions. The solution is validated with 21 CFR Part 11 requirements and is built on the PTC Windchill platform. It also allows companies to track, govern and manage GUDID submissions throughout the entire process.
“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.”
For more information, visit PTC.
Sources: Press materials received from the company and additional information gleaned from the company’s website.