PTC Submits Test Data to FDA’s Global UDI Database




PTC recently announced it has successfully submitted Unique Device Identifier (UDI) data to the preproduction version of the US Food and Drug Administration (FDA)’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 reduce the instances of patient injury and death that result from the misidentification of medical devices.
 
Medical device manufacturers need to implement compliant processes and technology to meet the UDI requirements and avoid any potential negative consequences. The FDA’s first UDI compliance deadline for high-risk Class III devices is September 24, 2014. High-risk devices are identified as the most complex, life-sustaining, in-body electronic medical devices—these include pacemakers, defibrillators, vascular stents, and ventilators.
 
This compliance can allow for accurate tracking of “as implanted" device configurations and the ability to ensure that faulty devices are updated or not (as in case of, e.g., deceased patients or removed devices for whatever reason). In the past, it was hard to accurately identify all active units and make sure that they were fixed on a timely basis. As the software content of medical devices increases, companies must now also consider developing software patches for such devices.
 
PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill product lifecycle management (PLM) platform, the PTC UDI solution is a preconfigured software solution, validated in accordance with 21 CFR Part 11 requirements, designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. Any PLM software vendor that targets the medical devices industry will have to follow PTC’s suit if they haven’t already done so.
 
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