“Our goal was to shorten the time and cost it takes breakthrough medical devices to move through the pipeline from development to assessment to final review,” HHS Secretary Kathleen Sebelius said in a video statement. “It is beginning to create a culture that embraces change.”
The three products selected from 32 applicants are an implantable renal assist device developed by the University of California at San Francisco; a wearable artificial kidney, by Blood Purification Technologies of Beverly Hills, Calif.; and the Hemoaccess Valve System, designed by Greenville, S.C.-based CreatiVasc Medical.
The initiative was launched in February 2011 and the first submission it considered was a brain-controlled, upper-extremity prosthetic.
The agency chose advanced kidney-disease technology as the focus of its subsequent phase of the program because it affects more than half a million Americans and cost Medicare more than $29 billion in 2009.
The modified program will allow participating developers to obtain assistance from FDA officials before submitting to the pre-market approval process on the development of a benefit-risk profile for their product and a mapped out regulatory path for it.
“It is clear that there is a need for earlier and more flexible interaction between developers and the agency, and the innovation pathway has begun to provide that approach,” Sebelius said.
The leading industry trade group praised the expansion of the accelerated approval program.
“Early interaction with developers well before a device is submitted to FDA for review can be critical in speeding an innovative technology through the FDA review process and into the hands of physicians and patients,” David Nexon, senior executive vice president for the Advanced Medical Technology Association, said in an e-mailed statement. “We commend FDA for expanding its Innovation Pathway initiative to more devices and encourage them to move as rapidly as possible to include other innovative device categories, especially those that treat patient conditions for which there are few, if any, options.”