New FDA Rule on "unique device identifier" (UDI) Marking Requirements

In September, 2013, the FDA released the final rules requiring that most medical devices sold in the United States have a “unique device identifier” (UDI). Unless exempt, the label and device package of each medical device must include a UDI in both a plain-text version and in a form that uses “automatic identification and data capture” technology, such as a bar code. In addition, a device designed to be used more than once and reprocessed before each use must be directly marked with a UDI. Stand-alone software must also be directly marked.

A UDI is a unique numeric or alphanumeric code that consists of two parts:

• a device identifier that identifies the labeler and the specific version or model of a device, and
• a variable production identifier that identifies one or more of the following:
  • the lot or batch number within which a device was manufactured;
  • the serial number of a specific device;
  • the expiration date of a specific device; and/or
  • the date a specific device was manufactured

The FDA is creating a new Global Unique Device Identification Database, into which every device manufacturer is required to submit specific information. A draft guidance document describing the role of the new database is available on the FDA website.

The UDI requirements are being phased in over time. The schedule of when the rules will apply to certain types of devices is also available on the FDA’s website here.