FDA Grants Implant Manufacturers a One Year Extension on UDI Labeling Compliance

November 20, 2014 Haley Lentz

On November 19, 2014, the Food and Drug Administration released a one year extension on UDI labeling compliance for many implantable medical device manufacturers. Implantable medical device manufacturers with devices that meet all of the following criteria (1) classified with primary codes and regulations listed in the November 19 extension letter, (2) single use implants, and (3) intended to be sterilized (or cleaned and sterilized) before use, will now have until September 24, 2016, to adapt labeling requirements set forth by the final rule.

The UDI final rule mandates that all medical device labelers must include a unique device identifier (UDI) on the labels and packages of medical devices distributed in the United States. The UDI must be displayed in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology. The UDI Rule also requires labelers to submit specified product information to FDA’s Global Unique Device Identifier Database (GUDID).

Implantable manufacturers meeting the requirements set forth in the November 19, 2014, extension letter must still meet submission requirements by the September 24, 2015, compliance deadline as set forth in the final rule.

For more information on the labeling and submission requirements established by the UDI Final Rule, please contact Haley Lentz at hlentz@reedtech.com.

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