Devicemakers may benefit from using specially created software to comply with the FDA’s new unique device identification submission and tracking requirements, rather than creating their own systems, some experts say.
If the software “can assure consistent compliance … envision the various scenarios by which it will be used and can be depended upon, it will be useful,” Steven Niedelman, lead quality systems and compliance consultant at King & Spalding, said
The FDA recently published its final UDI rule, changing how devicemakers label their products. The rule specifies the technical requirements for a UDI, which consist of two portions:
The device identifier, which lists the specific version or model of the device; and
The production identifier that more precisely identifies the specific device through information such as lot or batch, serial number or expiration date.
While devicemakers can create their own software solutions to comply with UDI, it’s not as efficient, said Mohan Ponnudurai, industry solution director for software company Sparta Systems. “This rule is pretty new … change is coming,” he said, and if devicemakers write their own software, they will need to alter it each time the rule changes, rather than just acquiring an upgrade, Ponnudurai said.
Sparta Systems aims to capitalize on the UDI guidance with software that’s designed to help devicemakers submit product information to the FDA’s Global Unique Device Identification Database. The TrackWise UDI eSubmission Manager performs packaging and transmission to the GUDID gateway and gives an acknowledgment of receipt, which is tracked to provide traceability for the initial UDI registration, the company says. Any product changes initiated through TrackWise Change Control are handled the same way, maintaining the history of UDI updates, it adds.
Ponnudurai noted the system will also comply with European UDI requirements, when issued, which will likely vary in some ways from the FDA’s UDI system.
While software can offer an advantage, devicemakers should carefully vet any systems before adopting them. Niedelman has often heard manufacturers say “that software limitations prevent a firm from being compliant, and enhancements to modify or update are too expensive, difficult or inconvenient to perform.”
“If it is designed correctly and it works well, terrific. If it will become an encumbrance, it will become the fall guy for noncompliance,” he said.
Niedelman has repeatedly urged devicemakers to get a head start on complying with the UDI rule, noting that it is more than a simple labeling rule and will impact all aspects of what companies do day in and day out.
Makers of Class III devices still have a year to set up a UDI system, but can apply now for a year-long extension. Class II device manufacturers must implement the system in three years, and Class I devicemakers have five years unless they are exempt from the requirements.
The Unique Device Identification System is the newest system to track medical devices in the U.S. and around the world. But are you ready for what it will require of you? The FDA Unique Device Identification (UDI) Rule It’s Ready for You, Are You Ready for It? will prepare you for this new regulation. Sign up today.