Helping Medical Device Companies Comply with the FDA’s Ruling Regarding Unique Device Identification System
Sparta Systems Inc. officials announce the release of TrackWise UDI eSubmission Manager. TrackWise is the company's award winning EQMS that is used by leading medical device companies for complaint handling, adverse event reporting, non-conformance investigation, Corrective Action/Preventive Action (CAPA), registration tracking, and other quality and regulatory processes. The release marks Sparta's fifth supported electronic reporting standard which includes support for eMDR and eMDV electronic submission processes.
The new FDA ruling calls for labelers to submit product information concerning medical devices to FDA's Global Unique Device Identification Database (GUDID), unless they are subject to an exception. Specifically, it requires that product registration data is packaged and submitted to GUDID using XML transport and delivery. The TrackWise UDI eSubmission Manager performs this packaging and transmission to the GUDID gateway. Once the GUDID gateway receives the information, it sends back an acknowledgement, which is tracked as an integrated part of the workflow. This provides the traceability for the initial UDI registration. Any subsequent product change, initiated through TrackWise Change Control process is handled the same way, effectively maintaining the history of UDI updates as required by regulation.
In addition to handling UDI product information submission, Sparta Systems recognizes the wide range of impact the newly required standard will have, and is already working consultatively with medical device and combination products companies to understand and make the required changes to their quality processes and systems.
"Our close, strategic relationship with many of the leading medical device companies allowed us to proactively build this product in advance of the final ruling from the FDA," states Mike Jovanis, Sparta Systems' vice president of product management and strategy. "We are proud to deliver an immediate solution to our customers that will not only help them comply with the new ruling, but also allow them to quickly begin implementation given the narrow window mandated by the FDA."
The full FDA ruling can be found at here.