FDA UDI Regulation Impact on Medical Device Labelers

The FDA UDI Regulation Impact on Medical Device Labelers webinar presented by subject matter expert, Jonathan Bretz, provides specific recommendations and a 3-Step Plan of how to plan for, implement and follow through to meet the requirements of this new regulation, its global impact, benefits, definitions, key compliance timelines (September 24, 2014 for Class III/PHS Act devices) and why this is a “publish or perish” regulation.


Screen Shot 2014 04 09 at 4.26.39 PM FDA UDI Regulation Impact on Medical Device Labelers

About Your Instructor

Jonathan C. Bretz, MBA has Over 35 years medical device experience including Regulatory Affairs/Compliance, Submission experience [510(k), CE Technical Files, Health Canada], Quality Systems (QSR, ISO 13485), Risk Mitigation (ISO 14971), Regulatory Strategies, UDI/GTINs, Product Development, Marketing & Sales, Operations and Supply Chain Management. Jon can be contacted at 617-356-7776, or jbretz@rsqmassociates.com


Blog Excerpt from “What is UDI and Why It Matters.” 

“In this blog, “What is UDI and Why It Matters” the author reviews the fundamentals of UDI, FDA’s Final Rule applications and its global significance. 

FDA’s Final Rule (Federal Register – UDI Definition) states a Unique Device Identifier (UDI) is a code that sufficiently identifies a medical device throughout its distribution and use. The UDI is comprised of a static component, “Device Identifier” (DI) and a dynamic component, “Production Identifier” (PI). 

The DI itself is made up of your Labeler Identification Code and a code that pinpoints the specific version or model of that device. PI, on the other hand, includes manufacturing information for that specific device, such as lot or batch number, serial number, expiration date or manufacturing date (both in YYYY-MM-DD format).” 

FDA Unique Device Identifier Final Rule