Resources for Food and Drug Administration (FDA)

Unique Device Identification for FDA Compliance

Regulatory Affairs Professionals Society

The recent announcement from FDA about Unique Device Identification (UDI) affects all medical devices and is a major undertaking being supported by members of Congress, hospitals and patent safety organizations. This Webcast provides an FDA perspective on this hot topic and a forum for questions and answers.

Learning Objectives: Upon completion of this Webcast, participants should be able to:

Summarize the history of CDRH’s UDI initiative;
Explain CDRH’s purpose for UDI;
Discuss the next steps that are to be taken with this initiative.
Target Audience: Large and small manufacturers of medical devices, including capital equipment and disposables, and personnel involved with regulatory affairs, quality assurance, manufacturing, purchasing and hospital/customer management are encouraged to attend.

Speakers:

Frank Pokrop, Manager, Regulatory Affairs, Siemens Molecular Imaging Group
Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, US Food and Drug Administration
Larry G. Kessler, ScD, Director, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration
Cost: RAPS Members: $325 USD; Nonmembers: $400 USD

Cost is per site—unlimited participants!

Registration: Register online or call iLinc at 1.800.651.7916 to register by phone. (Registration information at www.raps.org/webcasts.)

Connection Instructions: Registered sites will receive, via email from iLinc, a link to a PDF file containing presentation handouts and complete instructions for connecting to the webcast.

View the Resource

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