Another medical device association declares that the FDA clearance process for devices, contrast agents is ‘broken’ – Surprise, Surprise

In a recent article, the Executive Director of the Medical Imaging & Technology Alliance (MITA), Dave Fisher, expressed his frustration with the FDA and its user fees program, citing a stalled clearance process for contrast agents and increases in 510(k) review time.

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

The FDA user fees authorized by Congress and paid by the medical device manufacturers are intended to make new technologies available to the public more quickly by enhancing FDA/manufacturer communications and improving FDA performance. It is interesting that between 2008 and 2012, medical device companies will have provided the agency with nearly $300 million in user fees but the time for FDA 510(k) review has increased by 13% in 2009 and 34% in 2007 (as reported by the Office of Device Evaluation's 2009 Annual Performance Report)

Additionally, during the last FDA user fee negotiations the FDA committed to publishing guidances for industry to make the clearance process 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 (not most) cases.

Mr. Fisher went to state that 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."

Medical Imaging & Technology Alliance (MITA) is just one Association that spoke out on the state of current 510(k) review process. There are many medical devices without any Associations to petition or lobby on their behalf. The FDA review process has returned to the quagmire it was back in the early 1990’s. Review times are being increased due to new inexperienced reviewers, Congressional oversight and a “not” so friendly FDA.

What will 2011 bring will depend on the upcoming election. Change can only come with a change in the oversight.