![]() ![]() SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. Participants can also augment their project with NIH contract research organizations (CROs) that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. 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. 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. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. 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.Īctivities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the U.S. NOT-DA-22-050 - Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint Medtech: Small Business Translator (U44) See Notice NOT-OD-21-170ĪpExpanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-169.ĪugUpdate: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See NoticeĪugNew NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. SeptemUpdates to the Non-Discrimination Legal Requirements for NIH Recipients. OctoReminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After JanuNew Grant Application Instructions Now Available. NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After JanuNew Grant Application Instructions Now Available See Notice NOT-OD-23-092.ĭecemNotice of Early Expiration of RFA-NS-21-022 "Translational Neural Devices (U44 Clinical Trial Optional)". FebruNotice of Change to Minimum Performance Standards for SBIR and STTR Applicants.Notices of Special Interest associated with this funding opportunity
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