FDA Releases 510(k) Report and Plan of Action

The FDA's Center for Devices and Radiological Health (CDRH) released a report summarizing public comments related to initial recommendations released in August 2010, as well as a plan containing 25 actions for implementation in 2011. 

LifeScience Alley's and its 510(k) Action Committee have been tracking FDA's process of reviewing and making changes to the device approval program, providing input to CDRH, to a national coalition, and to key legislators representing Minnesota and its device industry.

Statement of Response to Today's Report and Plan of Next Steps

The 510(k) Action Committee looks forward to reviewing FDA's report and plan of action in depth over the coming days.  We recognize the difficulty in improving the 510(k) program while taking into consideration the viewpoints of all related stakeholders.  We applaud FDA and Dr. Shuren for operating an open process that has enabled stakeholders to offer real input and engage in productive dialogue with CDRH leadership.

As demonstrated by recent studies (including one from the University of Minnesota), the 510(k) system has a remarkably good safety record.  Therefore, we are pleased that FDA has committed to focus planned actions on increasing transparency and predictability in the 510(k) program.  Streamlining the de novo process, enhancing training for review staff, and clarifying the circumstances requiring clinical data submissions are all positive changes that reflect many concerns communicated to FDA over the past several months.

We are concerned about the deferred decisions on seven issues identified as "problematic", and hope that FDA will continue to incorporate our concerns into a timely decision process. 

As the Institute of Medicine (IOM) continues to conduct its independent review of the 510(k) program, we remain concerned about the lack of representation of many key stakeholders on the committee.  We hope the IOM review process will provide opportunities for input from a broad range of constituents.

We look forward to continuing an open dialogue with FDA to ensure that patients have greater access to life-saving and life enhancing medical innovations, and will support FDA's efforts in any appropriate manner as the process moves forward.

For more information, visit www.LifeScienceAlley.org/Advocacy