OPPORTUNITIES

Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3)

ISSUED BY: National Institutes of Health

Summary/Description

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility Study). The small clinical study should provide data to answer key questions about the function or final design of a device.This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study.

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General Information:

FUNDING OPPORTUNITY NUMBER:

RFA-NS-16-009

FUNDING MECHANISM:

Grant

DATE POSTED:

September 17, 2015

LAST UPDATED:

September 17, 2015

EXPIRATION DATE:

April 26, 2016