Path to CDRH Approval: Practices and Preferences of FDA Medical Device AdCom Members
This article describes, based on survey results, how Medical Device Advisory Committee members prepare for meetings and the key factors that influence their thinking.
For many Premarket Approval (PMA) submissions and supplements, a Medical Device Advisory Committee panel meeting is a required step toward product approval by the US Food and Drug Administration (FDA). A positive recommendation from the Advisory Committee is critical to approval; in the last five years, the Center for Devices and Radiological Health (CDRH) has followed the advice of its committees to approve or not approve a product 89% of the time. An important part of the Sponsor’s preparation process is understanding how panel members prepare for the meeting and what factors influence their votes. Using the resources of our firm, 3D Communications, the authors conducted a survey of current and former members of FDA Medical Device Advisory Committees to determine how they prepare and the key factors that influence their thinking.
This study first appeared in Regulatory Focus. Complete the form to view the complete findings.
ABOUT THE AUTHORS
Susan Resnick, PhD, has 20 years of experience in clinical research, medical device technology and regulatory strategy. As a scientific executive at 3D Communications, she guides clients through critical meetings with FDA, including Advisory Committee meetings. She has published more than 35 articles in peer-reviewed medical journals. Connect with her on LinkedIn
Christopher Miller, MS, is a biostatistician with extensive experience in the design, analysis and interpretation of clinical trials. Prior to joining 3D Communications, he was a senior biostatistician at NAMSA. Miller has published more than a dozen articles in peer-reviewed medical journals. Connect with him on LinkedIn.
The authors would like to acknowledge Amy Tezel, Jim DiBiasi and Katie Clark of 3D Communications for their critical comments and feedback on an earlier draft of this manuscript.