Getting Ready for the FDA’s Unique Device Identifier System
Wednesday, February 5, 2014
1:00 PM - 2:30 PM ET
After several years’ delay, the Food and Drug Administration (FDA) has at last released this rule on medical device safety. Now it’s time to understand the effects for device manufacturers and hospitals. In short, most medical devices distributed in the United States must contain a unique device identifier, or UDI, particularly if it is intended to be used more than once. Product information must be submitted by the labeler to the FDA’s Global Unique Device Identification Database (GUDID).
A UDI system has the potential to improve the quality of information available regarding medical devices. This may enable the FDA to identify product problems more quickly and improve patient safety, such as by issuing a recall of an ineffective or faulty product. The FDA collaborated with the device industry as well as patient groups in developing the new rule.
• Gain an overview of the UDI rule and its potential impact on health care-related industries.
• Understand the provisions of the FDA’s final rule as well as some of the exemptions and the compliance dates.
• Discover the HIT/EHR perspective as ONC has been working steadily on this part of UDI implementation.
• Learn about potential challenges as well as the areas where implementation may be seamless.
Who would benefit most from attending this program?
Legal practitioners who advise health care clients; medical device industry professionals; professionals in the hospital industry.
Program Level: Basic-Intermediate
Prerequisite: A general understanding of health care regulations.
CPE Delivery Method: Group Internet-Based Live
Field of Study: Specialized Knowledge and Applications
Recommended CPE Credit: 1.5 credits
Anticipated CLE Credit: 1.5 credits (may vary based on from which location requested)