Improving Communications Between FDA, Sponsor, and Advisory Panel

• Activity Number: 536
• Type: Roundtables
• Date/Time: Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
• Sponsor: Section on Health Policy Statistics
• Author(s): Gary Lynn Kamer*+
• Companies: U.S. Food and Drug Administration/CDRH/OSB/DBS
• Keywords: Sponsor ; Panel ; Pre-IDE ; Pre-PMA ; Communications

Abstract

This discussion will identify the information the manufacturing sponsor of a medical device needs to provide to FDA to improve the efficiency of the required FDA review of the safety and effectiveness of the device. Some of this information may be useful prior to the sponsor's submission of an original Investigational Device Exemption (IDE). Other information may be necessary only after the completion of the testing and studies required under the IDE, but prior to the submission of a Pre-Market Application (PMA). The PMA describes the implementation of the tests and studies performed, as well as their results. More importantly, the PMA provides the sponsor's justification for the marketing of the medical device, based on it's safety and effectiveness as demonstrated by the analyses of the data. Also, the need for effective communications between the sponsor, FDA and FDA Advisory Panel members will be examined. Examples will be provided.