Path to CDRH Approval: Practices and Preferences of FDA Medical Device ADCOM Members
by Susan Resnick
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, an Advisory Committee (ADCOM) meeting is a required step toward product approval by the FDA. A positive recommendation from the ADCOM 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 themselves prepare for the meeting and what factors influence their votes. Using the resources of 3D Communications, the authors conducted a survey of current and former ADCOM members 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.