Top 9 UDI Compliance Challenges

Top 9 UDI Compliance Challenges - Webinar CD/Transcript

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Jay Crowley, the man who wrote the UDI rule, dicusses what he views as the top 9 challenges that devicemakers face in complying with the final rule.

Implementation is mandated in stages over the next few years, but truth be told, most companies are nowhere near compliance.

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If you're like most device manufacturers, it's your first opportunity to get up close and personal with what the FDA is requiring of you in the coming years.

To help you, Mr. Crowley has identified the following 9 questions as the key challenges for the industry, and will provide implementation tips, best practices and in-depth answers to them:

  1. What if I have a manufacturing date on my label? Do I need to include it? Many manufacturers put a date on the label — but don’t use it for control purposes and don’t want to put it in UDI. But now it’s the law.

  2. What day do I use in the standardized date format? Some manufacturers have never included day in the expiration date; using only year and month. But the final rule requires that a specific day be included.

  3. What is the correct Global Medical Device Nomenclature (GMDN) term for my device or combo product?

  4. How do I select the proper LABELER Data Universal Numbering System (DUNS) for businesses globally?

  5. I’m confused about implantable devices. Are extended wear contact lenses implants?

  6. How do I handle some of the most complex compliance challenges, such as kits, convenience kits and combination products?

  7. How far reaching is the UDI requirement? For example, what are the requirements for orthopedic trays?

  8. What is the secret to understanding and navigating all of this packaging hierarchy?

  9. At which point in the process does it make the most sense to assign a new device identifier?

It's no exaggeration to say that the FDA’s UDI rule impacts every device company and applies to multiple parts of each organization’s quality systems. This is not a rule that can be overlooked. 

Order the webinar CD and transcript set and you will also receive these invaluable documents to help with your company's transition to the new rule:

  • The slide deck from Mr. Crowley’s presentation
  • A complete collection of FDAnews articles focusing on the UDI rule
  • Full text of FDA’s Unique Device Identification System Final Rule
  • FDA’s Global Unique Device Identification Database (GUDID) Draft Guidance
  • International Medical Device Regulators Forum's revised document on the Unique Device Identification (UDI) System for Medical Devices

SPECIAL BONUS: Not sure your company will be ready by the FDA’s published deadlines? (Your first deadline could be as soon as September 24, 2014.) There is a way to apply for exemptions, extensions or alternatives, but you must understand the right way to approach the FDA. In this bonus take-away, Mr. Crowley will tell you how.

So, the Top 9 UDI Compliance Challenges: Former FDA UDI Chief Provides Answers webinar CD and transcript set? You'll get an insider's understanding of the complex nuances of UDI, detailed answers to your toughest questions and tips to help with implementation. Order today.