The FDA has made strides to improve its medical device review pathways, but what's the real-world experience for medtech companies?
Reuters recently reported that a growing number of U.S. cardiologists are expressing frustration with the lack of availability of newer cardiac devices in the United States as compared to Europe. Their beef: U.S. patients have to wait longer for access to beneficial next generation therapies.
Sound familiar? The debate over U.S. versus European regulatory approaches for medical devices certainly is not new. It's something we've been hearing and reading about since 2008/2009, when U.S. device clearances and approvals seemed to slow even further behind those in Europe.
When manufacturers raised an alarm, the agency responded by citing poor submission quality. But by 2011, FDA ceded to the need for improvement to its 510(k) clearance and PMA approval processes. So much so that Dr. Jeffery Shuren, the agency's director of the Center for Devices and Radiological Health, smartly held a series of "town hall" meetings in key medtech cities, including Minneapolis, Boston and San Francisco. While we weren't in attendance, we admired his action and could only imagine the body armor Dr. Shuren had to don for the feedback sessions with manufacturers. (Question for another day: is body armor Class I?)