Final Rule Issued on Unique Device Identification System

The FDA released the unique device identification system Final rule, which will bring consistency to the process of identifying medical devices, finalizing the Proposed rule which was issued on July 10, 2012 (77 FR 40736). Among the goals of the system is help identify problems, target recalls and respond to adverse events, address counterfeiting and diversion, and improve patient safety, by requiring an identifier to be included on devices’ labels, with certain exceptions. The system will be phased-in, focusing first on the highest-risk medical devices.

Stemming from a requirement contained within the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Final rule states that “[b]y making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.” Specifically, the system will (1) reduce medical errors; (2) simplify the integration of device use information into data systems; (3) provide more rapid identification of medical devices with adverse events; (4) provide for more rapid development of solutions to reported problems; provide for more rapid, more efficient resolution of device recalls; (5) better focused and more effective FDA safety communication; (6) standard format for dates provided on a device label; and (7) other additional benefits.

What is a UDI?

The Final rule will require all medical devices to carry a unique device identifier (UDI), which is a unique numeric or alphanumeric code containing: (1) a device identifier, a mandatory, fixed portion which shows the labeler and the version or model of the device; and (2) a production identifier, a conditional, variable portion that shows one or more of the following: the lot or batch number of manufacture, serial number, expiration date, date of manufacture, and the distinct identification code. The UDIs will be both printed in plain-text and in a coded format that allows for bar code-type scanning. Devices intended for multiple use and reprocessing must be directly marked with a UDI.

Database

The FDA will also develop a publicly searchable database, the Global Unique Device Identification Database (GUDID), so that the public can search information about the device. Labelers will be required to submit information about their devices to the GUDID. Personal information will not be contained in the database.

Compliance Dates

The FDA also provided compliance dates for various devices under the Final rule, as the system is phased-in.

  • 1 year after publication of the Final rule. Labels and packages of Class III devices and devices licensed under the Public Health Service Act (PHSA) must bear a UDI, with dates on labels formatted as required, and data submitted to the GUDID.
  • 2 years after publication. Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI, with dates on labels formatted as required, and data submitted to the GUDID. Life-supporting and –sustaining must bear a UDI that is a permanent marking on the device itself if the devices is meant to be used more than once or reprocessed, and such stand-alone software must also provide its UDI as required.
  • 3 years after publication. Class III devices must bear a UDI that is a permanent marking on the device itself if the device is meant to be used more than once or reprocessed, and labels and packaged of class II devices must bear a UDI, with dates on labels formatted as required, and data submitted to the GUDID. Class II stand-alone software must provide its UDI as required.
  • 5 years after publication. Class II devices must bear a UDI that is a permanent marking on the device itself if the device is meant to be used more than once or reprocessed. Labels and packages of class I devices and those that have not been classified into class I, II, or III must bear a UDI, and dates on all devices (even those previously excluded from labeling requirements) must have dates on labels formatted as required, and data submitted to the GUDID. Class I stand-alone software must provide its UDI as required.
  • 7 years after publication. Class I devices and those that have not been classified into class I, II, or III must bear a UDI that is a permanent marking on the device itself if the device it meant to be used more than once or reprocessed.