Update 8/27/2018
Unique Device Identifier Deadlines – 2018
Medical device labeling requirements differ from other regulated products because they are required to include a special barcode, a Unique Device Identifier, that is unique to each medical device. Obtaining an UDI involves a specific process with specific data requirements. FDA has updated the UDI Requirements Compliance Dates. The next date for class I, class II, and unclassified devices is September 24th, 2018. You can view all of FDA’s updated dates here.
Original Post 8/12/2015
Starting on September 24, 2015 a new FDA compliance deadline for Unique Device Identifiers (UDIs) on medical devices comes into an enforcement phase. FDA posted a non-definitive list of the affected medical devices, recommending that labelers check with CDRH to determine whether their devices fit the category. Since all Class III devices were subject to the first deadline for these regulations – September 24, 2014 – the devices newly required to bear UDIs are primarily Class II, along with some unclassified or Class I devices. Labelers must submit the data for these devices to the Global Unique Device Identifier Database (GUDID). If they have never done this before, they are in for a headache.
The devices which must now bear a UDI on their packaging and labeling include implantable, life-supporting, and life-sustaining devices, including life-supporting or life-sustaining software.
Those devices intended to be reused, and reprocessed before each use, must have the UDI permanently marked on the device itself – because the label and packaging will be removed and discarded. However, direct marking of the UDI is not required where it would interfere with the device’s safety or effectiveness, where it is not technologically feasible, or where the device is single-use and is subjected to further processing for an additional single use.
Stand-alone software must provide its UDI through a statement that is either displayed whenever the software is started or displayed through a menu command.
For more details on how to comply with the upcoming regulations, see our blog post Special Cases for UDI Requirements.
