UDI Direct Marking for FDA Compliance: Navigating New Rules

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UDI Direct Marking for FDA Compliance
Navigating New Rules

Confused by the FDA’s UDI direct marking regulations? What information should go on the label and the device itself? What methods of marking are acceptable? What’s the difference between a device identifier and a production identifier? What additional requirements are placed on reprocessed devices?

The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language.

Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance. In the FDAnewsBrief, UDI Direct Marking for FDA Compliance, Crowley lays out a path to compliance. He explains:

  • The technology necessary for creating and verifying bar codes
  • The difference between direct marking and direct part marking
  • How the rules apply to device components and accessories
  • Exceptions to the direct marking requirements
  • Record-keeping requirements
  • Testing to make sure any direct mark doesn’t affect the safety or performance of the device
  • UDI requirements in the premarket submission stage.

Order your copy of the UDI Direct Marking for FDA Compliance: Navigating New Rules and receive guidance from the man who wrote the FDA’s Unique Device Identification rules.

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Table of Contents

  • Introduction
  • UDI and Direct Marking Regulatory Framework
  • How the FDA Defines Reprocessing
  • Exceptions to the Direct Marking Requirement
  • And More …

View the entire TOC

Who Will Benefit

  • Regulatory Managers
  • Design Engineers
  • Labeling Specialists
  • Project Managers
  • Quality Managers
  • Quality Engineers

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