What is FDA's Critical Path Initiative?

The Critical Path Initiative is FDA's effort to modernize the scientific process of medical device regulatory review. According to Janet Woodcock, the private sector (you) has made massive investments in basic biomedical research, but regulators (FDA) have not kept pace with what they call 'regulatory science'. 

We know 'regulatory science' lags behind, what's being done about it?
'Regulatory science', the FDA's ability to review a new technology with expertise and insight, has lagged significantly behind the private sector. Under resourced and understaffed, FDA has struggled to keep pace with evolving technologies. The problem has been compounded by newly emerging applications like new molecular technologies, advanced imaging techniques, nanotechnologies, robotics, and more.

Last year FDA published a list of 76 examples of promising and high-priority projects the initiative will foster. Is your technology among them?
http://www.fda.gov/oc/initiatives/criticalpath/

Inspection Woes, Worries about Safety
Given the Government Accountability Office's report on improvements needed in drug safety, the investigative arm of Congress is calling for more establishment inspections. Last week Congressman John Dingell, D-Mich, held congressional hearings regarding the increase in FDA funding needed to inspect foreign establishments. FDA Commissioner Andrew von Eschenbach said the average inspection cost about $45,000. While the focus was on drugs, I think we can expect increased inspection activity in the device sector as well. http://www.gao.gov/new.items/d06402.pdf
http://money.cnn.com/

Will MDFUMA help?
The re-authorization of MDFUMA means a renewal and expansion the far-reaching changes made by FDAAA:  the new medical device user fee structure will enable BROAD changes to how FDA does business, including inspection of device establishments by third-parties;  a regulation on unique device identification; new requirements concerning pediatric devices and devices with potential for pediatric use; new restrictions of FDA advisory panel member conflicts of interest; new requirements for submission of information concerning clinical trials; the Sentinal Initiative to gather adverse event information from existing medical records, and more.

I want more...
You can listen to this informative e Conference on CD or On Demand.