FDA data transfer
EDITEL is a certified provider for UDI data transfer to the US
UDI (Unique Device Identification) is a world-wide system for the standardized identification of medical products which was passed by the US-based FDA (Food and Drug Administration) back in 2014. European manufacturers of medical products also have to meet these requirements if they want to export their products to the American market.
After a three-year transitional period, UDI must be implemented in Europe as well, starting in May 2020. In addition to unique identification and labeling of medical products, manufacturers have to maintain article mater data in a centralized database. All data needs to be reported to the GUDID (Global UDI Database). If manufacturers have limited data to report, manual entry via the GUDID web application is possible. To efficiently process larger volumes, there is the option of creating an automated interface.
As an official FDA third party provider, EDITEL offers its tried-and-tested solution for automated data transfer to the GUDID. The system relies on the EDI platform eXite to convert manufacturers’ in-house files to an HL7 SPF file. Subsequently, all data is validated and submitted.
A dedicated business monitoring tool keeps track of every submission and its successful completion. According to Gerd Marlovits, the CEO of EDITEL, this best practice solution and the close collaboration with GS1 Austria makes “EDITEL the provider of choice when it comes to automatically transferring UDI data.”