Director of 510(k) Office Will Retire This Month
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.
Devices & Diagnostics Letter
Hmm, I don't know. I know Ms Rosecrans and she always was rather bureaucratic and inflexible in her dealings with me. Maybe a change would be for the better?
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