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?)
Furthermore, at AdvaMed 2011, we heard Dr. Shuren deliver a keynote speech that detailed a several point plan to improve the device submission review process, including improved reviewer education and retention programs, and a senior-level committee – with Dr. Shuren himself – that would be called upon to rule whether a reviewer’s request for more data was valid. We were cautiously optimistic – not because we thought he was being disingenuous, but because we knew that making change in any large organization could be like moving a barge.
Flash forward to 2013. Many clients tell us they have great relationships with their contacts at FDA, and we’ve seen several achieve 510(k) clearance and progress toward PMA approval for their devices.
Yet, we have also heard from industry colleagues about submissions that have gotten lost, only to have the clock go back to zero when they are found. And we read articles like the above from Reuters.
The bottom line is that everyone wants access to devices that are both safe and effective. One can debate whether we are two steps forward and one step back in the United States, or if real progress is being made to the process. What has your experience been?
