The first of the UDI implementation deadlines for the FDA’s Unique Device Identifier (UDI) Regulation is approaching fast. Do you know when your medical devices must be labeled with a UDI? Read on to find out.
FDA requires higher risk devices be brought into compliance with the UDI regulations first. Compliance starts with Class III devices and devices licensed under the Public Health Service (PHS) Act (http://bit.ly/PHS-Act). Lower risk devices will follow.
1. June 23, 2014 is the compliance deadline for Class III and PHS Act device labelers to file a one-year extension. FDA requires extension requests be written (§801.55), documenting the number of labelers and devices subject to the request and explaining why an extension would be in the best interest of public health. FDA may also request additional information to help the Agency make a decision on this request. Federal Register – Class III Compliance Dates
2. September 24, 2014 is the first compliance deadline for labels and packages of Class III devices, Class III Stand-alone Software and devices licensed under the PHS Act to be “compliant.” These devices must have a UDI on its packages and labels, human readable dates must be formatted as YYYY-MM-DD (§801.18) and information submitted to the Global UDI Database (GUDID) (§830.300) by this date.
3. September 24, 2015 is the compliance deadline required for labels and packages of Implantable, Life Sustaining and Life Supporting Devices to have a UDI and corresponding data submitted to GUDID. Life Sustaining and Life-Supporting devices are also required to have UDI as a permanent direct mark if they are to be used more than once, and reprocessed before each use (§801.45). Stand-alone software that is life-sustaining or life-supporting must have a UDI per §801.50(b). Human readable dates on these labels must be formatted as YYYY-MM-DD.
4. September 24, 2016 is the compliance deadline required for Class II devices and Class II Stand-alone Software to be compliant. As with the device classes above, this means having the UDI on the device label and package (human readable date in YYYY-MM-DD format) and data submitted to GUDID. Class III devices intended to be used more than once and reprocessed between uses must have their UDI permanently marked on the device by this date.
5. September 24, 2018 is the compliance deadline for Class I devices and Class I Stand-alone Software, as well as devices not classified into Class I, Class II or Class III. This date requires devices to have a UDI on their labels and packages, and the human readable dates on labels must be in YYYY-MM-DD format. Class II devices intended to be used more than once and reprocessed between uses must be direct marked with their UDI.
6. September 24, 2020 is the compliance deadline for Class I devices, and devices that have not been classified as Class I, II or III intended to be used more than once and reprocessed between uses, must be direct marked with their UDI.
FDA’s UDI final rule will be phased in over time to ensure that labelers would have adequate time to build and test systems, and create the infrastructure needed to implement the regulation’s many requirements. FDA believes a phased approach will spread the cost and burden of implementation over a number of years. This approach, according to FDA, should promote “the efficient and effective implementation of the final rule.”
On-hand inventory labeled and packaged prior to the above deadlines has been extended a 3-year grace period in the Final Rule. This inventory does not need to be relabeled/repackaged with their UDI until three (3) years past the compliance date of their product Class compliance date. FDA considers consignment inventory to fall under this provision. This requires companies to track consignment inventory; ensuring it is used prior to the three-year grace period expiring. Any inventory – on-hand or consignment – remaining past the grace period will need to be relabeled and/or repackaged to be compliant. Federal Register – Existing Inventory