FDA Unique Device Identification

Custom-Fit Solutions for FDA Unique Device Identification

Recently, the Food & Drug Administration (FDA) issued a final rule requiring that most medical devices used throughout the United States contain unique device identification or UDI, in the form of a direct part marking or permanent, tamper-proof label.  These identification standards impact the distribution of Class I, II, and III medical devices and may present some implementation challenges to businesses serving the healthcare industry.  The same identification guidelines also apply to a number of combination products, which include medical devices that are licensed through the Public Health Services Act (PHS).

Benefits of a streamlined UDI system include improved information and analysis in adverse event reporting, target recalls, and even patient safety.  This FDA UDI rule was developed through years of thoughtfully working with the medical device industry and the healthcare community, as well as various patient and consumer groups.
At ID Integration, we deliver exceptional solutions for complex identification needs originating from our strong foundation of integration for stringent compliance standards, like those involved in the U.S. Department of Defense's military specification IUID program.  This expertise and proven track record makes our company a knowledgeable and trustworthy partner for applications resulting from these newly imposed UDI requirements.

FDA UDI Compliant Solutions
Intelligent scanners provide easy tracking and audit trails:

  • Smarter scanning bridges the gap between hospital data collection formats effortlessly.  [Read more about ID Integration's selection of intelligent bar code scanners using BarcodeOS ®.]

Broad range of compliant marking & coding solutions:

  • We offer a complete range of marking hardware for UDI labeling or direct part marking.  [Read more about marking solutions for Unique Device Identification.]

Contact our team to discuss complete, custom integration solutions to fit your individual business needs.
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