FDA Proposed UDI Rule Is Finally Here

July 21, 2012 | Blog | 0 comments

This month, cialis buy the U.S. Food and Drug Administration issued its long-awaited proposed rule for a Unique Device Identification (UDI) system requiring medical device manufacturers to uniquely identify their products using one of two industry standards (GS1 Global Trade Item Numbers (GTINs) or HIBCC Labeler Identification Code (LIC)) and then submit standardized product information to the FDA’s UDI database (UDID) to facilitate industry-wide accessibility. With everyone identifying the same products at the same unit of measure in the same way – manufacturers, buy viagra hospitals, distributors, group purchasing organizations (GPOs) – the healthcare industry hopes to increase patient safety, enhance product traceability and improve operational performance.

With the proposed rule issued, Jay Crowley, senior adviser on patient safety with the FDA’s Center for Devices and Radiological Health, is no longer being hounded with the question of “when” but is now dealing with questions related to “how” manufacturers can comply with the UDI rule.

Karen Conway, industry relations director at GHX, just published a series of blog posts that do an incredible job of explaining the proposed UDI system, manufacturer requirements and how healthcare providers can begin preparing to use product data standards within their organizations. Here is a link:

Seems the healthcare industry has been talking about product data standardization for quite some time.  Will be interesting to see activity in this area ramp up now that there is a U.S. regulatory driver behind it.

Kara L. Nadeau

Founder and President of KLN Communications, Inc.