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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from March 2023
This webcast will feature an FDA presentation on improving consensus standards to better allow manufacturers to cite them appropriately in device submissions. FDA will also discuss the importance of participating in standards development to optimize standards for regulatory use.
Price: $0 Member | $25 NonMember
Participants will be able to: (1) describe the attributes of a standard that is fit for regulatory use and (2) understand how to contribute to standards development.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory affairs and standards professionals
Scott A. Colburn is the Director of the Standards and Conformity Assessment Program at
the Food and Drug Administration’s Center for Devices and Radiological Health. In this
role, Scott is responsible for the Center’s standards recognition and related development
activities in 600+ national and international consensus standards committees. In addition,
Scott oversees the program’s new Accreditation Scheme for Conformity Assessment
(ASCA) Pilot program and the Center’s efforts to optimize standards for regulatory use
within the International Medical Device Regulators Forum.
Scott has served in numerous roles in the area of premarket review and voluntary
consensus standards development and implementation for medical devices. He is a
member of many national and international standards organizations and serves on several
policy and leadership committees.
Gail Rodriguez is a Senior Advisor to the Standards and Conformity Assessment Program (S-CAP) in FDA’s Center for Devices and Radiological Health. She is responsible for policy development and analysis related to the development and use of standards and leads S-CAP’s strategic planning and communications efforts. Prior to coming to the FDA seven years ago, Dr. Rodriguez served in various policy, sales, marketing and training roles in the radiopharmaceuticals industry, and in leadership positions for several diagnostic imaging associations. She earned her Ph.D. in Political Science, with an emphasis on health policy, from the University of Kansas.