CDRH director Jeffrey Shuren got an earful from attendees at a town hall meeting in Bloomington, MN. It was the first leg of a three-stop nationwide tour to meet with device makers and other stakeholders interested in the medical device approval process. Most speakers in the audience of about 400 in Minnesota bemoaned the difficulties they've experienced in trying to get devices approved. For example, some speakers said that the FDA approval process lacked predictability, which can be harmful for start-up companies looking for funding. Several others highlighted lengthy timelines and unhelpful agency staff.

For his part, Shuren listened carefully and patiently. He started the meeting by outlining his initiatives for the center, and later said, "I can say without reservation that we have no intention to scrap the 510(k) program." Shuren noted that some changes to the 510(k) process will be announced in a few weeks. We can't wait to find out what they are.