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Sept. 24 — Clinical studies to test investigational devices can now be approved by the FDA in about a month, when a few years ago the same process took more than a year, according to a Sept. 24 blog by two of the agency's device leaders.
The blog, “Strengthening the Clinical Trial Enterprise for Medical Devices: An FDA/CDRH Strategic Priority Update,” said that efforts at the Food and Drug Administration to advance the clinical trials program for devices has led to fewer review cycles and shorter overall review times for its investigational device exemptions, which are the authorization to conduct clinical trials on devices to collect safety and effectiveness data. The median number of days to full IDE approval decreased from 442 in 2011 to 101 in 2014, according to the blog. During 2015, the median number of days to full IDE approval has decreased to 30 days, the blog said.
“At the Center for Devices and Radiological Health (CDRH), we are committed to patients having access to high-quality, safe, and effective medical devices—as quickly as possible,” Owen Faris and Jeffrey Shuren wrote. “Innovation is key to both speed and excellence in that endeavor.”
Faris is the acting director of clinical trials in the CDRH's Office of Device Evaluation; Shuren is the director of the CDRH.
They noted the device center identified reducing the time and cost of the clinical trial enterprise in a February 2014 report on strategic priorities.
In addition to shorter review times, Faris and Shuren said, IDE applicants don't have to undergo as many review cycles at the agency. In 2011, they said, 15 percent of IDEs were approved within two review cycles; in 2015, 74 percent of IDEs were approved in two review cycles.
“This performance meets FDA’s strategic goals and, more importantly, means that important technologies have the potential to reach [U.S.] patients,” they said.
There also has been a jump in the CDRH's Early Feasibility Studies (EFS) program, where small clinical studies are designed to gain early insights into an innovative technology during development and before starting a larger clinical trial. They said there has been a 50 percent increase in the number of EFS submissions during the first nine months of 2015, compared with the same period in 2013.
They also highlighted a draft guidance on the benefits and risks for IDE decisions, as well as a draft guidance encouraging the use of adaptive designs for clinical trials and another draft guidance on adaptive clinical trial designs for devices.
“We are committed to making U.S. patients the first in the world to have access to high-quality, safe and effective medical devices,” they said. “We believe these results are clear evidence that we are moving the right direction, helping to ensure that robust and efficient clinical trials that provide appropriate human subject protections take place here in the U.S.”
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Shuren and Faris's blog is available at http://blogs.fda.gov/fdavoice/index.php/2015/09/strengthening-the-clinical-trial-enterprise-for-medical-devices-an-fdacdrh-strategic-priority-update/.
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