ProMedic is excited to advise you about an expansion of services related UDI compliance consulting.
What is UDI?
As you may know by now, FDA has instituted a new labeling requirement called Unique Device Identifier (UDI). UDI is a sophisticated bar code that will help with medical device recalls, adverse event reporting, tracking, and tracing as well as many other public health benefits identified by FDA. Eventually a UDI will be required to appear on the label of every medical device and each level of device packaging, with only a few exceptions.
What do I need to know now?
You should immediately identify all your medical devices and their respective FDA product codes (e.g., an endotracheal tube is FDA product code BSK).
Once you have identified your product codes, reference the attached PDF titled List of FDASIA Devices. If you have a product code on the attached list you will be required to implement and comply with UDI by September 24, 2015. UDI is to be phased in, with Life Saving / Supporting and Implantable Class II devices first, then the balance of all Class II in 2016.
|Device||UDI Compliance Date|
|Implantable/Life-saving/supporting (Class II, Class I & unclassified)||Sept. 24, 2015|
|Class II (all other non-I/LS/S)||Sept. 24, 2016|
|Class I, unclassified, or not classified||Sept. 24, 2018|
How can ProMedic help?
Should you have products that must comply with UDI in 2015, please contact us, if you have questions about how to get started.
We will be offering a range of services from General Information – What is UDI presentations to assisting to establish GUDID accounts, data collection for the 62 data elements to be uploaded in the GUDID, implementation including verification and validation, data entry, and regulatory support, and more.
Who to contact with questions?
We recognize that there will be questions, so please give us a call to start the conversation. UDI is complicated and it will require planning, resources, and personnel commitment.
Let ProMedic guide and assist you through the strategy, planning, and implementation process.