FDA Issues Draft Guidance for Direct Unique Device Identifier Labels

June 30, 2015 in News

On Friday, FDA released draft guidance detailing requirements for directly marking medical devices with a unique device identifier as part of FDA’s plans to create a new medical device surveillance system, FierceHealthIT reports (Hall, FierceHealthIT, 6/29).

Background

In September 2013, FDA issued a final rule establishing a unique device identification system for tracking medical devices, with the aim to:

  • Enable quick and efficient recall of medical devices;
  • Improve the accuracy and specificity of adverse event reports;
  • Offer a clear path for documenting device use in electronic health record systems and clinical information systems; and
  • Provide a secure, global distribution chain to address counterfeiting and diversion.

In February, FDA and the Brookings Institution — which has been commissioned to help oversee the surveillance system — released a report outlining a seven-year, $250 million plan to develop the medical device surveillance system (iHealthBeat, 2/23).

Draft Guidance Details

The draft guidance aims to improve FDA staff and medical device labelers’ understanding of the “direct marking” requirements for unique device identifiers (Walsh, Clinical Innovation Technology, 6/28).

The draft guidance states that the direct marking requirements apply to devices intended for long-term use, which are more likely to be separated from their original labels and packaging.

In the draft guidance, FDA said it will not mandate a specific method for the direct labels, but suggested:

  • Attaching a permanent plaque to equipment;
  • Affixing a permanent tag, such as a radio frequency identification; or
  • Etching the label on the device.

In addition, FDA said it is seeking feedback on how the labeling should be completed for devices that are designed to be cleaned and repurposed with sterilization or disinfection.

FDA will accept comments on the draft guidance until Sept. 24 (FierceHealthIT, 6/29).

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