Bulletin 12-16

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Reminder - Seeking Comments on Proposed Rule

- Unique Device Identification System

Bulletin 12-16

October 2, 2012

In the July 10 issue of the Federal Register (77 Federal Register 40736), the Food and Drug Administration (FDA) announced the availability of a Proposed Rule titled "Unique Device Identification System." This 44-page document can be viewed and downloaded at:

https://www.regulations.gov/document?D=FDA-2011-N-0090-0001

This rule proposes to establish a unique device identification (UDI) system for medical devices. Since some medical devices may contain allograft tissue, this rule can affect tissue banks and it has the potential to additionally impact labeling a tissue bank could select for conventional tissue grafts. The proposal describes that "each UDI would have to be provided in plain-text version and in a form that uses automatic identification and data capture (AIDC) technology," such as a bar code or 2D matrix.

In general, the proposed rule includes: new definitions; identifies some exceptions; standardizes the formatting of dates; a device database would be developed; expectations to conform to certain international standards; and, a phase in period over several years would occur.

The AATB Executive Office is collecting comments and recommendations. Comments to the proposed rule are due to be submitted to FDA by early November 2012 so your comments should be submitted to Scott Brubaker by October 24, 2012.

To properly submit comments to AATB:

  • identify the specific section and reproduce the paragraph relevant to your comment;
  • make a specific recommendation; and
  • provide a rationale in support of your recommendation.

This FDA website also offers useful information:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm