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OpenR61Clinical trial: Optional / allowed

Translational Neural Devices (R61/R33 - Clinical Trial Optional)

National Institutes of Health (NIH) · NIH Institute/Center · PAR-25-053

Source: Grants.gov · View original posting ↗

Award
Amount not listed
Deadline
Jan 28, 2027
Letter of intent
Mechanism
R61
Duration
Expected awards
Funding cycle
Standard NIH dates
Open date
Oct 29, 2024
Total funding
Clinical trial
Optional / allowed
GovernmentSmall businessHigher educationNonprofitForeign entities

Research areas

Biomarkers & diagnosticsTherapeutics & drug discovery

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This NOFO is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

Data notes: award amount not published in the source feed; administering NIH institute could not be identified from the opportunity number.