The new FDA rule requires that a label with the device package must be submitted for each medical device and must include a Unique Device Identification (UDI). The UDI must be in plain text and in a form that uses Automatic Identification and Data Capture (AIDC) technology to automatically identify objects.
The UDI rule calls for product information concerning medical devices be submitted to FDA’s Global Unique Device Identification Database (GUDID) unless they are subject to an exception. Specifically, it is required that product registration data is packaged and submitted to GUDID for transport and delivery. Once the GUDID gateway receives the information, it sends back an acknowledgement which is tracked as an integrated part of the workflow.
To meet the needs of medical device manufacturers, Sparta Systems a provider of software solutions has released their “TrackWise UDI eSubmission Manager”. The software will be used by medical device companies to handle complaints, report adverse events, investigate non-conformance, for corrective and preventive action registration tracking, and for other quality and regulatory processes.
This enables the initial UDI registration to be tracked. Any subsequent product changes, initiated through the TrackWise Change Control process is handled the same way and effectively maintains the history of UDI updates as required by the regulation.
In addition to handling UDI product information submission, Sparta Systems understands the impact that the newly required standard will have and is already working consultatively with medical device and combination products companies to make the required changes needed to their quality processes and systems to meet the FDA rule.
For more information, go to www.spartasystems.com.