On Sept. 24, 2013, U.S. Food and Drug Administration (FDA) issued its final rule on its Unique Device Identification System (UDI) after months of commentary from stakeholders. Principal changes in the final rule include new exceptions, compliance deadline extensions, exception request procedures and the phasing out of FDA legacy codes. AdvaMed commended FDA for listening to industry concerns in developing this UDI system for postmarket surveillance and medical technology improvements, but warned that the seven-year implementation process will be costly and burdensome if not implemented correctly.
The final rule requires all medical device packaging and labels to include an UDI, unless there is an exception or alternative placement. Each UDI on a device will consist of a plain-text code and then a digital code that allows the device identifier to be entered or scanned into an electronic patient record or other similar computer system. Similarly, there will be a Global Unique Device Identification Database (GUDID) to serve as a repository for medical device identification. While the system was designed to make sure patients receive the right devices in their care, FDA requires adverse event and product defect reporting to the GUDID to improve public safety and further product development.
Following are key changes and additions in the final rule:
I. New General Exceptions from the UDI Requirement:
- A medical device that has already been manufactured and labeled prior to the compliance date established by FDA for its particular class temporarily falls under the exception. The exception expires three years after the compliance date.
- A Class I device exempted from good manufacturing practices requirements of 42 CFR 820.
- Individual single-use identical devices distributed together in a package and not intended for individual commercial distribution, provided that implantable devices are not included in the exception and the device package itself must bear an UDI.
- Devices intended for export.
- Devices packaged within an immediate container of a combination product or kit; provided that the outside product or kit contains an UDI.
- A combination product that already contains a National Drug Code (NDC), provided that each device constituent of the combination product must bear a UDI unless specified otherwise in the regulations.
- No UDIs are required on any shipping container.
II. Special Label Requirements for Stand-Alone Software
- Stand-alone software that is distributed digitally rather than in package form meets the UDI requirement by (i) displaying a readable plain-text statement when the software is started; or (ii) displaying a plain-text statement through a menu command.
III. Single Process for Exception Requests & Legacy Codes
- FDA may grant exceptions or alternatives upon request if FDA feels that satisfying the request is in the best interest of public health.
- FDA may extend the compliance date for Class III devices for up to one year.
- Any labeler may use any exception or alternative granted by FDA.
- By Sept. 24, 2018, all NDC and National Health Related Item Codes (NHRICs) assigned to any medical device will be rescinded in favor of the UDI system. Any labeler assigned an FDA labeler code for NDC and NHRIC may continue to use that code for UDI issuances if they submit a request to FDA no later than Sept. 24, 2014.
If you have any questions regarding the guidance, please do not hesitate to contact the authors.