There is little question that medical imaging is entering a new golden age of innovation. However, according to the Medical Imaging & Technology Alliance (MITA), the U.S. Food & Drug Administration (FDA) may be putting Americans’ health in jeopardy by needlessly complicating and slowing the 510K clearance process.

This criticism of the FDA comes at the same time the Medical Device User Fee and Modernization Act (MDUFMA) has come up for reauthorization. The act is designed to improve communications between medical device manufacturers and the FDA and make the 510K clearance process faster and more efficient. In just the first four years of the act—from 2008 to 2012—manufacturers are expected to pay nearly $300 million in user fees.

However, the review time has, instead, been increasing substantially with it being 13% slower in 2009 then it was in 2005, according to the Office of Device Evaluation’s 2009 Annual Performance Report. It should be noted that the all-time high, according to the report was in 2007 when it was 34% longer than 2005.

According to a MITA press release, the organization is particularly concerned about how the clearance process has become mired for imaging devices. Recently published guidance that was intended to clarify how imaging products that physicians may utilize with contrast agents has made the clearance process for these devices more complicated, effectively freezing the process for these imaging products. According to MITA, 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. 

MITA will continue working with the FDA and Congress to ensure that an MDUFMA reauthorization would foster continued innovation in the medical imaging and radiation therapy device industry and improve patient access and care, according to the group.


(Source: Press Release)