RFA-HL-26-020
Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)
Summary
Briefing: RFA-HL-26-020 – Catalyze Product Definition Medical Device Prototype Optimization
Research Focus
This R33 Exploratory/Developmental Grants Phase II supports early-stage translational development of medical devices, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases and disorders. The program funds prototype testing, design modification, assay development for diagnostic disease targets, and research tool development—work positioned between basic discovery and in vivo testing. Projects should demonstrate novelty and represent significant improvements over existing solutions. Successful completion is expected to position products for subsequent in vivo optimization, safety, and efficacy testing through NIH or other federal and private funding. The program explicitly excludes clinical trials.
At-a-Glance
- Who can apply: Not stated (see full FOA for institutional eligibility)
- Funding & project length: Not stated
- Award mechanism: R33 (Phase II exploratory/developmental grant); clinical trials not allowed
- Key dates: Applications due February 11, 2025 (earliest cycle); December 24, 2027 (expiration); earliest start date July 2025
- Best fit for: Biomedical engineers, device developers, and diagnostic researchers advancing prototype-stage innovations in cardiovascular, pulmonary, hematologic, or sleep medicine toward preclinical optimization
Additional Context
This is part of the broader Catalyze program, which provides milestone-driven project management and development guidance. A companion R61/R33 NOFO (RFA-HL-26-019) supports earlier-stage prototype design; separate initiatives address small molecule/biologics therapeutics and enabling technology platforms. Submit via NIH ASSIST, institutional S2S, or Grants.gov Workspace.
Key Facts
Deadline
Thu, December 23, 2027
Posted
Fri, November 22, 2024
Award / Year (direct costs)
$500,000
Keywords
Research Areas
Gotchas (3)
Clinical trials are explicitly not allowed under this R33 mechanism, but the FOA does not clearly define what constitutes a 'clinical trial' in this context, creating ambiguity about whether certain h
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Source Text
“RFA-HL-26-020: Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)”
The NOFO was updated March 31, 2025 to align with agency priorities, with an explicit instruction to 'carefully reread the full funding opportunity and make any needed adjustments to your application
85%
Source Text
“This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.”
The FOA references a companion NOFO (RFA-HL-26-019) for 'earlier stage projects (initial prototype design/testing)' but does not clearly articulate the boundary between what qualifies for this R33 ver
80%
Source Text
“A companion NOFO (RFA-HL-26-019) is available for earlier stage projects (initial prototype design/testing).”