Grant opportunity · PAR-25-383
Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
Who can apply (as listed)
- For-profit organizations (other than small businesses)
- Others (see the opportunity text)
- Small businesses
- Special district governments
- Independent school districts
- City or township governments
- Native American tribal organizations (other than federally recognized governments)
- Private institutions of higher education
- County governments
- Native American tribal governments (federally recognized)
- Public housing authorities / Indian housing authorities
- State governments
- Public and state-controlled institutions of higher education
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility 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 clinical feasibility 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…
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