Grapefruit USA Inc (GPFT)

[IMGG4TP]

BUST, I know you want to get the Director of the CDRH and Shuren in on this conversation, but nobody is questioning his title and authority. The subject of Hindsight's query, as you acknowledged in #25372, was Rosecrans, the Director of the 510(k)Office of Device Evaluation, and it is clear, if you read the news release carefully, below, that she and her office are not only in the loop, but at the center of the decision making process, and therefore, by extension, have a considerable influence on the final destination of Dean's application.


"A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Heather Rosecrans, director of CDRH’s 510(k) Office of Device Evaluation, is retiring Sept. 15, FDA spokesman Dick Thompson said. Her departure could be another example of the ongoing turnover at CDRH, John Romans, CEO of BioMedix Vascular Solutions, said, adding that the turnover has resulted in a loss of institutional memory, contributing to the lack of predictability in the clearance process."