US FDA Delays UDI Compliance Deadline for Some Single-Use Implantable Devices
Medical device regulators in the US have extended their Unique Device Identification compliance deadline to September 24, 2016 for some implantable medical devices to provide more time for manufacturers of these devices to develop and implement workable UDI processes.
In order to qualify for the extension, a device must meet three key criteria:
- Device is classified with product codes and regulations listed on the FDA letter to implant labelers
- Device is considered a single-use implant
- Device is intended to be sterilized before use
Examples of medical devices qualifying for the extended UDI compliance deadline are bone plates and screws, metal surgical meshes, non-degradable soft tissue fasteners and intervertebral fusion devices.
The FDA’s move to delay UDI compliance for these devices follows a proposal from US medical device industry trade group AdvaMed earlier in 2014 for UDI information to be recorded at the point of use for some orthopedic devices that require separation from their original packaging and labeling in order to be properly sterilized and cleaned before implantation. Accordingly, the FDA has opted to grant qualifying manufacturers additional time in order to develop methods to make their devices’ UDI information available at points of use.
Deadlines for submission of UDI data to the FDA Global Unique Identification Database (GUDID), however, remain unchanged for all manufacturers. Class III devices must comply with GUDID submission requirements by September 24, 2014; implantable devices falling under Class I, II or unclassified categories must comply by September 24, 2015.