MITA Expresses Concerns About FDA Communication and Performance

Washington, D.C. – At a public meeting hosted today by the Food and Drug Administration, Dave Fisher, Executive Director of the Medical Imaging & Technology Alliance (MITA), provides an evaluation of the medical device user fee program. The FDA convened the meeting as part of the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).

The fees authorized by MDUFMA and paid by manufacturers, are intended to make new technologies available to the public more quickly by enhancing FDA/manufacturer communications and improving FDA performance. Between 2008 and 2012, medical device companies will have provided the agency with nearly $300 million in user fees.

“MITA supports a medical device clearance process that ensures safe and effective products are cleared for market in a timely manner,” said Fisher. “However, we are concerned that the link between fees and performance has broken down.”

According to the Office of Device Evaluation’s 2009 Annual Performance Report, FDA’s average 510k review time to final decision has continued to increase since 2005, the last year in which all submissions have been decided upon.  Even without considering open submissions, review times have increased between 13% (in 2009) and 34% (in 2007). 

Additionally, during the last MDUFMA negotiations the FDA committed to publishing guidance to industry in order to clarify and make transparent the clearance process. 

While we are encouraged by the leadership Dr. Shuren has articulated regarding a renewed commitment to a clear, consistent and appropriate application and clearance process, we can unfortunately point to examples where the process has become mired.

Specifically, a recent guidance intended to clarify how imaging products that physicians may utilize with contrast agents has actually made the clearance process for these devices more complicated and it appears that the clearance process for these imaging products is now effectively frozen. Contrast agents are pharmaceuticals which enhance certain types of medical imaging.  Because of the current confusion, some manufacturers are considering “defeaturing,” or removing some basic contrast agent technologies, in order to move their products through the FDA process and onto the market.  As this happens, physicians must either rely on older equipment that retains the contrast agent features or purchase new products that don’t include the innovations.  In both cases, patients and physicians won’t get all of the information they need to make medical decisions.

“FDA’s mission is to protect patients and promote innovation.  By turning back the clock on technology, the contrast agent guidance misses the mark on both counts,” said Fisher.

MITA looks forward to working with the agency and Congress to ensure that a MDUFMA reauthorization fosters continued innovation in the medical imaging and radiation therapy device industry and improves patient access and care.