UDI Final Rule
The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The UDI is a unique code made up of two parts. The DI is the device identifier which is mandatory and identifies the labeler and specific version or model. The PI is the product identifier which is a conditional part of the code identifying items such as lot number, serial number, expiration date, manufacture date, etc.
Compliance and Exemptions
There are different compliance dates depending on which category your device falls into. High risk devices must comply first and then they phase through lower risk categories. Class III devices must comply with the new rule within a year of final passing, implantable devices that are life-sustaining or life-supporting that are not Class III devices must comply within two years, Class II devices must comply within three years, and Class I devices must comply within five years.
There are several exceptions to the compliance rules. “ Section 801.30(a)(1) of the final rule provides an exception for a “finished device manufactured and labeled prior to the compliance date that applies” to the device, but this exception “expires with regard to a particular device 3 years after the compliance date that applies” to the device.” If a device is not yet completed or has not been labeled the exception will not apply.
Requirements for a UDI
The UDI must be issued by an accredited agency. The FDA does not indicate which type of AIDC technology you must use and will accept identifiers that are part of the ISO 15459 series of standards. Manufacturers must then submit the device data to the FDA Global UDI Database (GUDID) and update data such as the manufacturer and contact information, a version number of the device, etc. when necessary. The data will be made available to the public so that users of a medical device can access information about their device.
Accredited Issuing Agencies
The FDA is in the process of approving accredited issuing agencies. The FDA states, “We believe the UDI system will be best served if qualified private organizations that have relevant experience operate the day-to-day technical aspects of the UDI system. In addition, we have removed the provision that would have allowed a State agency to serve as an issuing agency. Although FDA may act as an issuing agency if it is necessary or appropriate for us to do so.” The FDA will announce decisions on issuing agencies as they become available.
Things to consider
Here is a brief look at what to consider now that the FDA has finalized the UDI rule.
- Ascertain which of your devices require a UDI and which ones will have to comply first.
- Be aware of all of your compliance deadlines and exemptions.
- Choose a standard. The FDA will accept identifiers that are part of the ISO 15459 series of standards.
- Determine if your label must be placed directly on the product or onto the packaging.
- Check your current packaging/product and evaluate how it may need to change to adapt to the requirements of the UDI.
- Assess how the UDI will affect your manufacturing and/or packaging procedures.
For a general overview of the UDI rule and compliance dates: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#agencies
To read the information on the FDA’s final UDI rule: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system