Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

Funding Opportunity PAR-21-282 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size 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 effectivenesting, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) 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. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, com...
Source: NIH Funding Opportunities (Notices, PA, RFA) - Category: Research Source Type: funding