On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, a relabeler, or any other person who applies a label to or modifies a label on a device that will not be modified again before sale—to place a unique device identifier (“UDI”) on the label and packaging of medical devices both in plain-text and also using automatic identification and data capture (“AIDC”) technology. The UDI itself will not hold any information. Manufacturers would have to submit identification information to FDA. FDA would aggregate the manufacturer-provided information in a new Global Unique Device Identification Database (“GUDID”). This public database would allow a physician to scan or manually enter the UDI of a device at a patient’s bedside and quickly access complete information regarding the device’s key attributes and proper use instructions.

The expected benefits of the new program include:

  • Reduce Medical Errors.
  • Simplify the Integration of Device Use Information into Data Systems.
  • Provide for More Rapid Identification of Medical Devices With Adverse Events.
  • Provide for More Rapid Development of Solutions to Reported Problems.
  • Provide for More Rapid, More Efficient Resolution of Device Recalls.
  • Better-Focused and More Effective FDA Safety Communication.
  • Provide an Easily-Accessible Source of Definitive Device Identification Information.

Although the UDI program will affect all classes of medical devices, there are a number of exemptions, in particular for Class I devices. FDA is seeking industry comments on the program, its timing and possible exemptions.

Comments on the proposed rule must be submitted by November 7, 2012. Click here for a more detailed discussion and analysis of the proposed rule and its implications.