On July 10, 2012, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (77 Fed. Reg. 40736) to establish a unique device identification (UDI) system for medical devices. This proposed rule would implement the requirements added by the Food and Drug Administration Amendments Act of 2007 (FDAAA) that require an identifier on the label of every medical device that guarantees that the device can be tracked through its distribution and use.

Summary of Proposal

Under the proposed rule, a UDI would include:

  1. a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and
  2. a production identifier, which includes the current production information for a device (e.g., lot or batch, serial number, expiration, date of manufacture, etc.).

This rule requires the label of a medical device to include a UDI, except in certain circumstances where the rule provides for an alternative placement of the UDI or provides an exception. In some instances, such as devices that are intended for use over a long period of time and are likely to be separated from their labeling, the rule would require the UDI to be placed directly onto the device.

The proposal would also exempt several categories of devices, including:

  • non-prescription devices sold at retail establishments;
  • devices delivered directly to hospitals and other health care facilities;
  • class I devices exempted from good manufacturing practice (GMP) requirements;
  • devices used solely for research, teaching or chemical analysis (not intended for clinical use);
  • custom devices, investigational devices, veterinary medical device and export-only devices;
  • devices held by the Strategic National Stockpile;
  • devices for which performance standards have been established by FDA;
  • combination-product device-constituents that cannot be used apart from the combination; and
  • single-use members of convenience kits.

Timeline for Implementation

The timeline for implementation provided in the proposed rule states UDI labeling requirements would be phased in over a multi-year period, based on the level of risk of the device, as follows:

  • one year after the promulgation of the final rule for class III devices and devices licensed under the Public Health Service Act;
  • three years after the promulgation of the final rule for class II devices; and
  • five years after the promulgation of the final rule for class I devices.

Interestingly, this timeline will need to be expedited, in part, based on the user fee legislation, Food and Drug Administration Safety and Innovation Act (FDASIA), that was signed into law on July 9, 2012. Section 614 requires a final rule within six months after the comment period closes, and requires the timing for all implantable, life-saving and life-sustaining devices to come into compliance within two years of finalized regulations.

What this Means for the Device Industry

The UDI is intended to provide an array of benefits for supply chain management, including:

  • reduction in the risk of medical errors;
  • rapid and accurate data acquisition, recording and retrieval;
  • more rapid identification of devices with adverse events;
  • more rapid development of solutions to reported problems;
  • more rapid and efficient resolution to device recalls; and
  • more effective and narrowly tailored FDA safety communications.

However, this also means that manufacturers, particularly makers of high-risk class III products, will have to understand and implement UDI systems quickly in order to comply with the law. Under FDASIA, this will also apply to all implantable, life-saving and life-sustaining devices, many of which fall under a class III classification, and some of which are already subject to device tracking requirements.

FDA is accepting comments on this proposed rule until November 7, 2012 (Docket No. FDA-2011-N-0090). The proposed rule can be found here.