FDA Hosts Second 510(k) Town Hall Meeting

The second in a series of public town hall meetings was hosted by the FDA on Tuesday, June 22, 2010 in Woburn, MA.  The meeting was again led by Dr. Jeffrey Shuren, the Director of CDRH, and had over 400 attendees who voiced their concerns with the 510(k) review process and listened about how the FDA is planning to examine it.

MDMA President and CEO Mark Leahey attended the meeting along with other MDMA members from the New England region to emphasize the concerns that small and mid-sized medical device businesses have with the current regulatory environment.

"As Dr. Shuren and other officials at FDA continue to meet with industry leaders and stakeholders, it becomes more clear just how concerned entrepreneurs are about the future of medical device innovation," said Leahey.  "At the end of the day, everyone agrees that protecting and improving patient care remains the top priority, and we must ensure that the regulatory process is reasonable and efficient to achieve these goals."

The third and final town hall meeting is currently scheduled to be held in Los Angeles, CA sometime in October.