Summary
The purpose of this announcement 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, 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 FOA 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.
Eligibility
- Nonprofits Non Higher Education Without 501c3
- Private Institutions of Higher Education
- Other
- Native American Tribal Organizations Other Than Federally Recognized Tribal Governments
- Special District Governments
- Public and State Institutions of Higher Education
- For Profit Organizations Other Than Small Businesses
- County Governments
- Independent School Districts
- City Or Township Governments
- Public and Indian Housing Authorities
- Nonprofits Having A 501(c)(3) Status With the Irs Other Than Institutions of Higher Education
- Small Businesses
- Native American Tribal Governments Federally Recognized
- State Governments
Funding categories
- Income Security and Social Services
- Health
- Education
Official source and attribution
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Open the official federal record