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Regulatory News | 11 February 2016 | By Michael Mezher
Officials from the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) say their efforts to develop a "regulatory toolkit" for sponsors has helped promote medical device innovation in the US, according to a recent viewpoint in JAMA Ophthalmology.
While fostering innovation has been one of CDRH's strategic priorities since 2010, reports that growth in device clinical trials in the US had fallen behind other countries, including Brazil, China, France, Germany and India, prompted the center to focus its efforts on improving the environment for domestic trials.
Out of concern that slowing growth in clinical trials could ultimately lead to a decline in innovative devices in the US, CDRH set goals for two critical areas for device clinical trials: improving the speed in approving investigational device exemptions (IDEs) and the number of early feasibility/first-in-human studies (EFSs).
Through its efforts, CDRH was able to reduce the time it took to review IDEs from a median 442 days in FY 2011 to just 30 days in FY 2015. Deborah Kotz, an FDA spokesperson, told Focus that CDRH also approved or conditionally approved 165 IDEs in 2015, the most in a single year since 2002.
According to the authors, the agency was able to meet these goals in part due to finalizing its guidance for EFSs, giving sponsors more clarity on the amount of data required to support EFS approval.
"The FDA acknowledges that completion of all nonclinical testing prior to initiation of an EFS may not be necessary when relevant nonclinical testing methods are not available or are not adequate," the authors write.
Additionally, the guidance includes a table for device evaluation strategy (DES) to help sponsors determine what information they need to support an EFS with limited nonclinical testing.
The authors also credit FDA's presubmission program with encouraging "direct collaborations" between manufacturers and the agency, and allowing for "distinct opportunities … to obtain feedback."
Internally, CDRH has established division-level teams to help sponsors prepare future EFS applications.
Within CDRH's Division of Ophthalmic and Ear, Nose and Throat Devices (DOED), a dedicated email address has been established to provide sponsors with direct access to the division's EFS team, who "are committed to responding to all inquiries within 2 business days."
Kotz also told Focus that CDRH plans "to establish mailboxes like this for each [CDRH] division in the near future."
The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States
Tags: Investigational device exemption, IDE, Early feasibility study, EFS