Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)
ID: 335384Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/335384

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-21-282.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)" aimed at supporting small business concerns (SBCs) in the development of therapeutic and diagnostic devices for disorders affecting the nervous or neuromuscular systems. This cooperative agreement program encourages SBCs to engage in translational activities and limited clinical studies, providing funding for prototype development, regulatory compliance, and clinical trials, with a focus on milestone-driven projects that involve NIH staff in planning and monitoring. The initiative is designed to enhance innovation in the biomedical field and improve patient access to safe and effective medical devices, particularly encouraging participation from underrepresented groups in research. Interested applicants must submit their proposals by September 28, 2024, and can find additional information at the NIH grants website or contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov for inquiries.

    Point(s) of Contact
    OERWebmaster03@od.nih.gov
    Files
    Title
    Posted
    PAR-21-282-Full-Announcement.html
    PAR-21-282.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), has released a Funding Opportunity Announcement (FOA) intended to support small business concerns (SBCs) in developing therapeutic and diagnostic devices for nervous or neuromuscular disorders. The Blueprint MedTech initiative aims to facilitate the clinical translation of innovative medical devices, offering funding for prototype development, regulatory compliance activities, and clinical studies. The cooperative agreement model emphasizes milestone-driven projects with NIH involvement in project planning and monitoring. Key features include eligibility for clinical trials and the allowance for up to five-year project periods divided into Phase I (up to two years) and Phase II (up to three years). Applicants must demonstrate comprehensive supporting data for unique device technologies, a plan for device development, and strategies for regulatory submission, particularly concerning FDA engagement. Furthermore, the FOA encourages diverse participation, particularly from underrepresented groups in research. The initiative aims to enhance patient access to safe and effective medical devices, bolstering innovation within the biomedical field.
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