Polaris Biomedical sponsored this year's Rocky Mountain Regulatory Affairs Society (RMRAS) Annual FDA Update meeting, and I had the pleasure of spending the evening with some of Colorado's top manufacturers and regulatory professionals. Here is my breakdown of what went down, the big structural shifts at the agency, and what this all means for medical device teams on the ground. A Brand New Agency Map: The Shift to OII Mark Harris kicked off the presentations by walking us th