In an effort to remove some of the barriers that can slow innovative medical technologies from getting to market, the US Food and Drug Administration (FDA) announced today that it is launching a medical device innovation initiative to speed review and approval of “pioneering medical devices.”
Through this program , the FDA will provide assistance to developers of novel technologies early in the process—for example, by helping to identify appropriate clinical end points and key scientific questions so that developers do not waste time on irrelevant testing. The agency’s Center for Devices and Radiological Health (CDRH) hopes this effort can reduce the time the agency spends reviewing a device before granting a premarket approval application (which in effect grants a developer a license to market the product) to 150 days, about half the time current reviews take.
The first submission to the initiative (a pilot for the program) comes from the US Department of Defense’s Defense Advanced Research Projects Agency, which is trying to develop a brain-controlled prosthetic arm and hand designed to provide near-natural arm, hand, and finger motion for patients who lost such function because of spinal cord injury, stroke, or amputation. The device uses a microchip implanted on the surface of the brain to record neuronal activity, decode the signals, and activate motor neurons to control the prosthesis.
The agency said the initiative will evolve, based on input from various stakeholders. To that end, the CDRH is holding a public meeting on March 15 and soliciting feedback until May 31 through a public docket. The CDRH will ask stakeholders for suggestions about such issues as eligibility criteria for the innovation initiative, how the agency will determine what types of technology should be allowed into the initiative (and at what point they would no longer be accepted as innovative products), appropriate time frames for review of submissions, and other actions the CDRH should take to facilitate the development, assessment, and regulatory review of innovative medical devices, while ensuring their safety and effectiveness.