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Getting Ready for the FDA’s Unique Device Identifier System


Product Code - LGN230
Speaker(s): Sonali P. Gunawardhana, Wiley Rein LLP; Evelyn Gallego-Haag, Office of the National Coordinator for Health IT; Terrie L. Reed, FDA, Center for Devices and Radiological Health
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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.

Educational Objectives:

• 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 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)

For additional information, please see the “CE Credit” tab.

Sonali P. Gunawardhana, Wiley Rein LLP; Evelyn Gallego-Haag, Office of the National Coordinator for Health IT; Terrie L. Reed, FDA, Center for Devices and Radiological Health

Sonali P. Gunawardhana, Wiley Rein LLP
Sonali Gunawardhana is Of Counsel in the Washington, D.C. office of Wiley Rein LLP. She draws on her nearly 10 years’ experience as an attorney at the FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing pharmaceuticals and medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers.

Ms. Gunawardhana earned an LL.M. from Washington College of Law, American University; a J.D. from the University of New Hampshire School of Law; an M.P.H. from Boston University; an M.A. from Webster University; and a B.A. from Syracuse University. She is licensed to practice in the District of Columbia, Maryland, and New York.

Evelyn Gallego-Haag, MBA, CPHIMS, Office of the National Coordinator for Health IT
Evelyn Gallego-Haag is a seasoned professional in leadership, management and consulting across the health, high-tech and government sectors. She is a trusted advisor in helping organizations bridge the gap between business requirements, technology and policy. Ms. Gallego-Haag also has a strong ability to work across diverse stakeholder groups having worked, studied and lived in Canada, the United States, and Europe. Her career has spanned health transformation and management, information technology, policy analysis, organizational design, strategic planning, business development, and health standards development. She specializes in Health Information Management (HIM) and Health Policy for both government and commercial healthcare organizations. Ms. Gallego-Haag is currently providing Program Management and Standards Analysis expertise to the Standards & Interoperability (S&I) Framework at the Office of the National Coordinator for Health IT (ONC). In this role, she serves as the Initiative Coordinator for two high-profile interoperability initiatives: Longitudinal Coordination of Care (LCC) and Structured Data Capture (SDC).

Ms. Gallego-Haag earned an International M.B.A. from the Schulich School of Business in Toronto, Canada and an M.P.H. Certificate in Health Policy from George Washington University. She is a recognized speaker and facilitator on various health IT topics including quality reporting, care coordination and meaningful use.

Terrie L. Reed, FDA, Center for Devices and Radiological Health
Terrie Reed is the Associate Director, Informatics at the FDA’s Center for Devices and Radiological Health. She is currently on temporary assignment as a Medical Device Safety Advisor to the Office of Chief Medical Officer, Office of National Coordinator for Health IT. In this capacity, she works with ONC staff to promote adoption of Unique Device Identification in ONC-related activities. The main emphasis of the detail is to facilitate the documentation, view, and transmission of UDI and associated standard device identification data – such as brand, model, contains latex – in electronic health information.

In conjunction with the detail, Ms. Reed continues to serve as Associate Director of Informatics at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB), where she leads the implementation of the recently published UDI Final Rule including the development and population of the Global Unique Device Identification Database (GUDID) as a master source of device information. She has led several data management initiatives including a joint project between the National Cancer Institute (NCI) and the FDA’s CDRH focused on improving and simplifying the device and patient problem codes used to code medical device adverse event reports. Prior to working in government, Ms. Reed worked for 13 years at a healthcare facility in Indianapolis in various positions as a process engineer, quality analyst, and medical information specialist. She holds an M.S. in Industrial Engineering.

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York*, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

*Bloomberg BNA is an accredited provider in New York for experienced attorneys only.

Hardship Policy
For information regarding Bloomberg BNA’s Hardship Policy, please visit the Continuing Education Information page.

Questions
Individual programs, subjects, and formats may not receive credit in some states and there may be specific rules regarding who may earn credit or the maximum number of credit hours that may be earned with specific formats. For specific questions, contact your state MCLE regulatory entity for specific questions about your MCLE rules or visit the American Bar Association’s website for general information on accreditation.

If you have further questions regarding a specific state or how to file for CE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator or send an email to accreditations@bna.com.