Update to the FDA’s UDI Regulation

Are you wondering what is happening to the FDA’s Unique Device Identification (UDI) regulation? Nothing is official yet, but the most recent information sheds light on an updated timeline for the FDA UDI roll out plan. The UDI standard is expected to be published in 2012.

The first set of deadlines is imposed on Class III medical devices. This class of devices consists of devices that support or sustain life, prevent impairment of health, or present a risk of illness or injury. An example is an implantable pacemaker.

By 2013, 12 months after the UDI standard is published, Class III devices must have a UDI mark on all levels of packaging. An engraved UDI may be required, and if a device has a serial number, then the UDI will also be serialized.

Class II medical devices will be required to follow FDA UDI guidelines 36 months after publication, by 2015. Class II devices include x-ray systems, gas analyzers, and pumps. Again, a UDI will need to appear on all levels of packaging.

The final group affected is Class I medical devices, which includes items like tongue depressors, examination gloves, and hand-held surgical instruments. This class of medical device will need to comply by 2017. The UDI will most likely be applied to the device, and not the packaging.

So medical devices that pose a potential risk to the patient and are critical to sustaining a patient’s life and health are affected first by the UDI regulations. Assuming that FDA’s UDI standard continues on track for publication in 2012, medical device manufacturers will need to have their plan in place for compliance.

Are you thinking about UDI regulations now, or wondering how to get the tools for compliance? Let us know. We can help you with labeling and marking so you can be sure you are following the UDI regulations.