FDA Releases Proposed Rule to Implement FDAAA Unique Device Identifier Mandate

By Jamie K. Wolszon –

Five years ago, Congress passed the FDA Amendments Act of 2007 (“FDAAA”), requiring FDA to promulgate regulations establishing a Unique Device Identifier (“UDI”) system to facilitate adverse event and recall tracking.  Under FDAAA, the UDI regulations must require an identifier on the label of each medical device specific enough to identify the device through distribution and use, unless FDA specifies an alternative location or makes an exception for a particular device or group of devices.  The law also states that the unique identifier may include the lot or serial number. 

Until recently, FDA solicited general public comment and held public workshops, but not much more (see here).  In particular, FDA had not issued a proposed rule.  The FDA Safety and Innovation Act (“FDASIA”) requires FDA to issue a proposed rule establishing a UDI system by December 31, 2012.  FDA must publish the final rule no later than 6 months after the close of the comment period, and must implement the final regulations for implantable, life-saving and life-sustaining devices no later than two years after FDA promulgates the rule, “taking into account patient access.”  FDC Act § 519(f), as amended by FDASIA § 614. 

FDA is now ahead of schedule.  After the House and Senate had passed the legislation, but before the President had signed it, FDA unveiled a proposed rule to implement the UDI mandate. 

FDA’s proposed rule breaks the UDI into two portions: (1) a device identifier, which identifies the specific version or model of the device and the labeler, and (2) a production identifier, which includes the current production information for a device such as the lot or batch, the serial number, expiration, or date of manufacture.  FDA would require that any organization wishing to issue UDIs receive FDA accreditation. 

Each UDI must be provided in plain text and in a form that uses “automatic identification and data capture” (“AIDC”) technology, according to the proposed rule.  AIDC is any technology (such as bar code, radio-frequency identification, or near field communication) that conveys the UDI or device identifier in a form that can be entered into an electronic patient record or other computer systems via an automated process.  FDA’s proposed rule would require submission of device information into a publicly available database, the Global Unique Device Identification Database (“GUDID”).  The GUDID will not contain any identifying patient information.

For certain categories of devices, FDA would require the UDI to be placed on the device itself instead of just the labeling: That requirement is proposed for devices that are used for extended periods of time and are likely to become separated from their labeling, including an implantable device, a device that is intended for reuse, and stand-alone software devices. 

FDA is proposing to exempt several categories of devices.  The rule would exempt over-the-counter devices sold at retail establishments; devices delivered directly to hospitals and other health care facilities; class I devices exempted by regulation from the Quality Systems Requirements in 21 C.F.R. § Part 820; products used solely for research, teaching, or chemical analysis and not intended for any clinical use; custom devices; investigational devices; veterinary medical devices; devices intended for export; devices held by the Strategic National Stockpile; and devices for which FDA has established a performance standard.  The production identifier would not be required for any class I devices.  In addition to the exempt categories, a labeler may request an exception or propose an alternative that would provide for more effective identification of a device. 

FDA has provided a 120-day comment period. A final rule would be phased-in over a multi-year period based on the level of risk of the device.  UDI labeling requirements would take effect beginning one year after the promulgation of the final rule for class III devices and devices licensed under the Public Health Service Act; beginning three years after the promulgation of the final rule for class II devices; and beginning five years after the promulgation of the final rule for class I and devices that are not classified. 

The marking requirement would go into effect two years after the base UDI labeling requirement goes into effect for that device; for example, for an implantable device that was class III, the marking requirement would go into effect three years from the promulgation of the final rule.

In addition to the UDI requirements, the proposed rule also proposes requiring a standard format to use on the medical device label whenever the label contains certain dates.