The Ombudsman requested that the Analysis Branch within the division conduct a study to collect the best practices to prepare for premarket meetings with the FDA. The ultimate product as a result of this study is a presentation outlining these practices. The Ombudsman wanted to also know if different types of meetings had different requirements. In order to collect this data, the Analysis Branch conducted two focus groups of personnel from the reviewing divisions within CDRH. There were a total of seventeen participants who ranged from project managers to Division Directors. The result of the focus groups was a set of charts with the advice from the focus group participants. It was noted that no significantly different advice would be given for the different types of meetings. Some of the major findings focused on preparing the background package and the essentials of keeping the meetings relevant to the scientific, regulatory or administrative issues identified in the background package. Additional advice ranged from simple comments like starting and ending on time, to the comments reminding sponsors that CDRH cannot approve a study or clear/approve devices during a one-hour meeting. The resulting charts from the study have been well received internally and all or part of the presentations will be used by both the CDRH Ombudsman and some reviewing personnel at various professional meetings.
PIC ID: 8135; Agency Sponsor: FDA-CDRH, Center for Devices and Radiological Health; Federal Contact: Wilkinson, Stephanie, 301-594-1284; Performer: (unknown),