The FDA Unique Device Identification Rule
It’s Ready for You, Are You Ready for It?
The UDI rule is final. Think you’re ready? Think again, because UDI is mandating changes that will hit your entire organization.
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 your entire operation, from creating adequate production and device identifier systems to labeling, marketing, packaging and adverse event reporting. You’ll need to identify as many as 55 data elements just to generate a UDI. It’s not simple.
Every change you make will also have to be incorporated in your SOPs and all your 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, you’ll 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 you mistakes to avoid; a healthcare provider who can tell you exactly what their needs are; and consultants who are working with companies just like yours 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
Donald Guthner, Principal, Orgenix, LLC