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FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
Date:11/4/2013

Falls Church, VA (PRWEB) November 04, 2013

The FDA Unique Device Identification (UDI) Rule
It’s Ready for You, Are You Ready for It?
**FDAnews Virtual Conference**
Nov. 19, 2013 — 10:00 a.m. – 4:00 p.m. EST
http://www.fdanews.com/UDIVC

Less than a year from now, all class III devicemakers will have to comply with FDA’s new UDI rule. Deadlines for other device classes follow in lockstep.

That may sound like plenty of time. It isn't.

This single requirement stretches across the entire operation, from creating adequate production and device identifier systems to labeling, marketing, packaging and adverse event reporting. Devicemakers need to identify as many as 55 data elements just to generate a UDI. It’s not simple.

Every change will also have to be incorporated in the SOPs and all employees trained.

Hospitals and purchasers are already updating their systems — and they’ll expect the companies they buy from to be ready, too.

In just one fast-paced day, attendees will hear from five of the top experts on UDI, including the man who wrote the rule; an early-adopter who’s implemented UDI and can tell attendees mistakes to avoid; a healthcare provider who can tell attendees exactly what their needs are; and consultants who are working with companies to implement UDI. The lineup includes:

  •     Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA
  •     Jackie Rae Elkin, Global Process Owner, Medtronic
  •     Rosalind Parkinson, Chief Supply Chain Officer, The Ohio State University, Wexner Medical Center
  •     Dan O’Leary, President, Ombu Enterprises LLC
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