Meetings with the FDA.
For new and innovative medical devices, a company is most likely to have direct communications with the FDA at some course during the product lifecycle. Most often these are meetings relating to what type of information is required in the marketing application (510(k) or PMA) and discussions relating to approval of the device. This session will explore the different types of meetings, preparation methods, and what to expect when you are at FDA. The discussion group leaders include a former FDA ODE Branch Chief who will provide his perspective. The format of this session is a discussion group, so please bring your questions and experiences to share.
Munzner
Robert F
RF
Bartoo
Grace
G