Lawrenceville, N.J.-based GS1 Healthcare US has released a guideline to help facilitate the implementation of the U.S. Food and Drug Administration's Unique Device Identifier Rule that requires medical devices to be labeled with a unique tracking code.
The implementation guide provides an overview of GS1 standards and the UDI rule, as well as specifics regarding unique production identifiers, barcode labeling and direct part marking.
GS1 was the first accredited UDI issuing agency, receiving FDA approval in December. Since then, Phoenix-based Health Industry Business Communications Council and San Bernardino, Calif.-based ICCBBA have also been accredited by the FDA to issue UDIs.
To download a copy of the UDI implementation guide, click here.
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