FDA's public 510(k) meeting is scheduled for tomorrow. Most observers expect the agency to weigh potential changes to this particular approval process and give some sort of indication as to where it is headed. CDRH leader Jeffrey Shuren says that the center wants input from a variety of people but "at the moment, nothing is imminent."

But that hasn't stopped the newly formed Minnesota Medical Device Alliance from scheduling its own discussion today about the 510(k) program. A steering committee for today's meeting in Minneapolis includes CEOs from several local start-up companies, device entrepreneurs, legal experts, and venture capitalists.