MITA: FDA clearance process for devices, agents is broken

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Citing a stalled clearance process for contrast agents and increases in 510(k) review time, the Medical Imaging & Technology Alliance (MITA) Executive Director Dave Fisher voiced industry frustration with the medical device user fee program, during a public meeting that was examining the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).

“We are concerned that the link between fees and performance has broken down," stated Fisher.

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.

According to the Office of Device Evaluation's 2009 Annual Performance Report, FDA's average 510(k) 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 percent (in 2009) and 34 percent (in 2007).  

Additionally, during the last MDUFMA negotiations the FDA committed to publishing guidances for industry to make the clearance proces  transparent. Although the agency has expressed a renewed commitment to a clear, consistent and appropriate application and clearance process, the process has become mired in some cases, according to MITA.

For example, a recent guidance intended to clarify how physicians may use imaging products 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.

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.

"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, who added that MITA "supports a medical device clearance process that ensures safe and effective products are cleared for market in a timely manner."