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Standards in Medical Device Submissions: Practical Advice on Appropriately Citing Consensus Standards to Reduce Regulatory Burden (On-Demand)

1.0 RAC Credits This webcast will explain the importance of consensus standards in medical device development and offer practical direction to device firms' regulatory affairs and standards staff about how to correctly cite standards in their submissions.
Standards in Medical Device Submissions: Practical Advice on Appropriately Citing Consensus Standards to Reduce Regulatory Burden (On-Demand)

This webcast will explain the importance of consensus standards in medical device development and offer practical direction to device firms' regulatory affairs and standards staff about how to correctly cite standards in their submissions.


Registration Fees

Members: $0
NonMembers: $25


Learning Objectives

Participants will be able to:

  1. Appropriately use and cite consensus standards in device submissions
  2. Include the correct documentation when standards are cited
  3. Understand FDA's standards recognition program
  4. Navigate FDA's standards web pages and databases to maximize proficiency in standards' utilization

Who Should Attend?

Regulatory affairs and standards staff


Audience Learning Level

Basic: Content is introductory and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or higher-level activities.


Speakers:

Scott Colburn

Scott Colburn
FDA

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 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.

Terry Woods

Terry Woods
FDA

Terry O. Woods is Chief Engineer for Standards & Strategic Outreach in the Standards & Conformity Assessment Program at the FDA’s Center for Devices & Radiological Health. Terry leads efforts to accelerate medical device development through the strategic use of consensus standards, works to promote conformity assessment, and the development of regulatory-ready standards to provide patients access to innovative, safe, and effective medical devices. As a White House Leadership Development Program Fellow, she helped lead the Results-Oriented Accountability for Grants Cross-Agency Priority Goal in the Office of Management and Budget.

Dr. Woods is a Fellow of ASTM International and served on the Board of Directors. She participates in standards development with numerous national and international standards organizations and serves in several leadership roles and policy committees. She is a Fellow of the American Institute for Medical and Biological Engineering and was named in the Top Ten Federal Engineers by the National Society of Professional Engineers in 2009. Woods earned her Ph.D. in Engineering Science and Mechanics from the Georgia Institute of Technology.

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