Unique Device Identifier (UDI) Rule Implementation and Compliance Guide

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Unique Device Identifier (UDI) Rule
Implementation and Compliance Guide

The next time you hear about UDIs, it may be from an FDA investigator. Will you be ready with an answer?

The rush to compliance is in full swing. By 2018 all devicemakers must be in compliance. It's already clear that implementation and compliance with this new rule is a very big challenge.

You'll need to understand what UDI is … who it applies to … what the exceptions to the rule are … what deadlines you must meet … what UDI issuing agencies are ... and how to work with them.

Thankfully, help is here.

Implementing UDI is a huge challenge. That's why FDAnews developed the new management report Unique Device Identifier (UDI) Rule Implementation and Compliance Guide.

It walks you step-by-step through the key portions of the UDI final rule, providing you with all the implementation and compliance details you need to know.

With Unique Device Identifier (UDI) Rule Implementation and Compliance Guide, you'll gain a clear understanding of this complex new rule and learn to work with it more successfully. You will learn:

  • The timetable for implementation;
  • Which devices must comply with the rule and which do not;
  • What information must be included on product labels;
  • How to submit device identification information to the GUDID;
  • About the accredited UDI issuing agencies and their roles;
  • And more.

Unique Device Identifier (UDI) Rule Implementation and Compliance Guide is fully updated to reflect the final rule, chapter by chapter the report includes the critical information you need to get down to the real nitty gritty of complying with the UDI rule.


PDF Edition

Available Format

PDF Edition — $397

Table of Contents

  • Introduction
  • FDA Implementation
  • UDI Basics and Goals
  • Data Submission and Standards
  • And More …

View the entire TOC

Who Will Benefit

  • Executives at device manufacturers
  • Data integrity and master data management teams
  • Supply chain executives
  • Healthcare providers
  • Device distributors
  • Group purchasing organizations

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