UDI rules and challenges medical device makers face

UDI rules and challenges medical device makers face

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

March 3, 2014
Manufacturing Group
Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

Jay Crowley, author of the UDI rule, will lead an in-depth 90-minute webinar focusing on what he views as the top 9 challenges that device makers face in complying with the final rule.

Top 9 UDI Compliance Challenges
Tues., March 11, 2014 – 1:30 p.m. - 3:00 p.m. EDT

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, 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. They are:

  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. 

Included in the webinar are:

  • Slide deck from 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

Not sure your company will be ready by the FDA’s published deadlines? (The first deadline could be as soon as Sept. 24, 2014.) There is a way to apply for exemptions, extensions, or alternatives, but you must understand the right way to approach the FDA.

Meet the presenter
Jay Crowley led the FDA team that wrote the UDI rule. As senior advisor for Patient Safety for CDRH,  Crowley developed the framework and authored key requirements for the FDA's UDI requirements. 

In December 2013, after a 27-year FDA career, Crowley became a VP of the UDI practice at USDM Life Sciences. USDM is a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry. USDM's professionals are recognized thought leaders in emerging life science computer system topics. They are experts in improving business value through the implementation and adoption of new technologies that run regulated business processes. 

Webinar PLUS Audio CD and Transcript: $467
Webinar Only: $267
Enroll online
Call: 703.538.7600 or 888.838.5578

Source: FDAnews