RFA-HL-26-019: Catalyze Product Definition - Medical Device Prototype Design/Testing, Diagnostics, and Assay Development (R61/R33)

RFA-HL-26-019: Catalyze Product Definition - Medical Device Prototype Design/Testing, Diagnostics, and Assay Development (R61/R33)

Executive summary

This opportunity is a U.S. National Institutes of Health (NIH) funding mechanism under the National Heart, Lung, and Blood Institute (NHLBI) Catalyze portfolio. It supports early-stage translational work moving basic ideas toward practical health products through a two-step, milestone-based structure. The program is designed for projects focused on medical devices, diagnostics, or research tools in heart, lung, blood, and sleep disorder (HLBS) disease areas.

The NOFO uses NIH R61/R33 exploratory/developmental phased support. The R61 phase supports initial prototype design and initial biological/technical validation activities, while the R33 phase supports advanced development once milestones are met. Clinical trials are explicitly not allowed. This is important because applicants proposing clinical protocol work will be out of scope, even if they are in adjacent preclinical or diagnostic domains.

The opportunity remains relevant for 2026 and 2027 because it includes recurring due dates and award cycles across multiple fiscal years. At the same time, expiration is set for the end of 2027, so this is a finite, active cycle opportunity rather than a historical archive.

What this NOFO is and does not provide

RFA-HL-26-019 is a product-definition grant, not final product development or commercialization financing. The focus is on proving feasibility and de-risking early-stage development through structured milestones and measurable execution milestones. In practical terms, this opportunity is best for teams that can show why their concept deserves an NIH-backed bridge from early concept to advanced preclinical readiness.

The NOFO is not:

• A general research award with open-ended exploration.
• A direct commercialization grant that immediately expects late-stage regulatory filing success.
• A clinical trial grant.
• A program for unrestricted project continuation from unrelated prior NIH awards.

The NOFO is:

• A phased translational grant.
• A structure with explicit progression gates.
• A program that expects applicant teams to think about IP and regulatory planning from the start.
• A mechanism tied to NHLBI’s broader Catalyze pathway and its preclinical follow-on stages.

At-a-glance details

Core scope: what project types are a match

The NOFO explicitly names three practical tracks:

1. Medical device prototype design and testing.
2. Diagnostics target identification and assay development.
3. Research tools for HLBS disease treatment and mechanistic study.

The program expects applicants to design work that can be sequenced in a phase-1 to phase-2 flow:

• R61: prototype concept, early design and testing, initial feasibility, assay direction.
• R33: deeper development, integration, optimization, verification, transition readiness.

This sequencing is more than a reporting formality. The NOFO states funding and transition are contingent on milestones and progress. Reviewers and NHLBI staff read applications as a development plan, not a collection of disconnected experiments.

Applications that are purely descriptive (for example a full product already near final preclinical regulatory readiness with no clear staged development plan) are often weak matches. Likewise, teams that only propose observational work without a product trajectory usually underperform against this framework. The strongest applications are those where each R61 activity produces a measurable evidence layer that justifies the requested R33 phase.

Who this is for

Strong fits

This opportunity is best for teams that can satisfy all of these:

• Have a clinically meaningful HLBS problem and a clear gap in current tools/devices/assays.
• Can explain biological rationale with preliminary data or literature-based grounding.
• Can frame a staged development roadmap in terms of measurable milestones.
• Can show readiness for partnership-driven development, including commercialization and regulatory pathways.
• Have a U.S. applicant organization that can handle NIH grant administration.

Better to skip this NOFO if

• You need clinical trial execution funding.
• You cannot submit through NIH systems with full compliance (SAM, UEI, eRA Commons, Grants.gov).
• Your work is purely basic without a near-term translational bridge.
• You cannot propose a feasible staged path from R61 outputs to R33 outputs.

Eligible applicant organizations

The opportunity is open to a wide set of U.S. entities including universities, nonprofits, small and non-small businesses, state and local governments, and some federal agencies, with standard NIH policy constraints for foreign eligibility. Foreign organizations themselves are not eligible as primary applicants. Foreign components inside a U.S. applicant are possible when NIH policy allows. This distinction matters in setup and compliance.

Even though the allowable organization list is broad, PI and organizational readiness usually determines feasibility. A technically strong project can still fail if the applicant organization cannot complete registration requirements on time.

Eligibility and applicant readiness checklist

You should complete each of these before drafting the narrative:

• Confirm your organization type is eligible.
• Verify SAM registration is active and includes UEI/CAGE where required.
• Ensure all required profiles are complete in eRA Commons.
• Confirm Grants.gov account status is active.
• Confirm at least one PI account if the same person is also Signing Official.
• Confirm no clinical trial is embedded in the project statement.

The NOFO explicitly warns that failure to complete registration before submission is not an accepted excuse for late submission. That is a hard operational constraint, not a soft recommendation.

Money and award structure

The budget model is straightforward but strict:

• Direct-cost cap: $300,000 per year for R61, and $300,000 per year for R33.
• The NOFO also references expected matching support for R33: non-Federal cash match 0.25:1 of R33 Federal direct costs.
• Program funds by fiscal year total up to $4,466,000 in FY26 and FY27 (and same in FY28) with up to 8 awards each year.

The match policy means R33 applicants should proactively plan for credible external support and clear documentation. NIH explicitly expects matching documentation before R61-to-R33 transition review.

Important practical implication

The NOFO does not treat this as two independent grants. R61 and R33 are coupled by performance milestones. A proposal cannot assume R33 funding as automatic second-stage continuation. You must show why phase progression is realistic, and how risks are reduced at each stage.

Timeline and deadlines (2026/2027 focus)

The NOFO contains recurring key dates across several review cycles. For users planning around 2026-2027, the relevant application windows remain active through 2027 and extend into the end of 2027.

Key cycle points visible from the official schedule

• 2026-02-11
• 2026-06-18
• 2026-10-21
• 2026-11-18
• 2026-12-16
• 2027-02-11
• 2027-06-17

The table on the source page also includes aligned review and award timing and indicates that not every due date supports every award action, so always confirm cycle notes before filing.

Deadlines are due at 5:00 PM local time of the applicant organization, and weekend/holiday shifts may apply automatically. Applications are strongly encouraged to submit early to leave room for corrections.

What to submit

The NOFO specifies several mandatory process requirements that are often overlooked by first-time NIH applicants.

Mandatory systems and pathways

• NIH ASSIST, or
• institutional S2S to Grants.gov + eRA Commons, or
• Grants.gov Workspace + eRA Commons.

Mandatory application content

The specific strategy section and project plan must clearly separate R61 and R33 objectives and milestones. Reviewers need to read the stage logic as a full sequence.

High-value required documents

• IP and Regulatory Strategies attachment (filename required: IP and Regulatory Strategies.pdf)
• Detailed milestones for both phases
• A timeline that shows progression and milestones from R61 into R33
• Clear project management plan with assigned responsibility
• Data management plan and resource sharing as required by NIH standard instructions

The IP/regulatory attachment is a practical gate. The NOFO marks applications without this attachment as incomplete for this program and potentially not peer reviewed.

Review and transition design

Transition from R61 to R33 is tied to milestone completion and evidence of non-Federal match plus accelerator support readiness. In practical terms, your R61 package should include:

• What is tested in phase 1 and why it decides phase 2.
• What external commercialization support exists or is realistically expected.
• What regulatory path you can begin defining at early stage.

The R33 transition language is explicit: by-review evidence, not future promise alone.

Evaluation mindset and common mistakes

RFA-HL-26-019 is evaluated by an NHLBI special emphasis panel. Standard NIH peer review procedures apply, with additional programmatic checks in this NOFO. Review expectations are not only scientific quality but also program compatibility: milestone clarity, stage realism, and execution capacity.

What reviewers look for in this NOFO

• Clear, stage-separated proposal architecture.
• Strong biological rationale and unmet need framing.
• Quantifiable milestones (not just broad intentions).
• Feasibility and risk management logic.
• Evidence of commercialization and regulatory awareness, especially as the project advances.
• A clear plan for reporting, project management, and budget justification.

Most common avoidable mistakes

1. Submitting a standard lab-only research plan with no staged R61/R33 logic.
2. Proposing clinical-trial-like activities.
3. Treating the project as an R33 request and not justifying R61-to-R33 transition gates.
4. Missing the required IP/regulatory attachment.
5. Underestimating registration/compliance setup time (SAM, eRA, Grants.gov).
6. Not budgeting for practical coordination costs, including innovation workshop participation and project management needs.

How to prepare an application that passes administrative checks

A strong strategy is to build a sequence of artifacts that maps directly to NOFO requirements.

Three-week planning block

Week 1:

• Confirm NOFO version and deadline cycle.
• Assign NIH admin lead for system setup.
• Draft milestones list with at least two milestones per phase.
• Confirm project fit (no clinical trial).

Week 2:

• Build Specific Aims split into R61 and R33.
• Draft innovation and technical novelty argument around HLBS gap.
• Prepare preliminary IP/regulatory outline.

Week 3:

• Complete resource and budget logic by phase, including match strategy for R33.
• Pull all mandatory attachments into final file naming convention.
• Run internal pre-review against NIH page requirements.

Submission week

• Submit at least 48-72 hours early to allow correction cycles.
• Track validation messages in eRA Commons and Grants.gov.
• Avoid last-minute replacements that affect file naming.
• Verify all required forms and attachments are present in the final package.

Practical advice on match and accelerator planning

Many teams prepare good science but weak transition planning. This NOFO is specifically structured around a staged commercialization pipeline. The practical implication is you should avoid designing a project that ends at data generation with no commercialization bridge.

The NOFO indicates an accelerator partner is required for R33 consideration. While evidence of an accelerator partner is not required at application time, evidence is required at transition. Still, teams should identify and begin engagement early. A prepared narrative that explicitly maps where commercial expertise is needed (device design, market positioning, pre-submission planning, IP strategy) can materially improve reviewer confidence.

Frequently asked questions

Is this NOFO currently useful for 2026/2027?

Yes. The opportunity includes recurring due dates and active review cycles through 2027, with an expiration date of 2027-12-24. In practical terms, this means there are multiple windows for 2026 and 2027 applicants.

Can foreign institutions apply?

Non-domestic organizations are generally not eligible as primary applicants. However, foreign components of eligible U.S. organizations may be allowed under NIH policy. Confirm the current NIH Grants Policy Statement definitions for your setup.

Is a clinical trial allowed at any stage?

No. The NOFO explicitly states clinical trials are not allowed. Any proposal dependent on clinical trial execution should be aligned to a different mechanism.

Is the applicant expected to secure all external match upfront?

Match documentation for phase 2 is expected to be demonstrated by transition review, not necessarily at the submission deadline. That does not mean there are no obligations; it means you need to build a credible match path that will hold at transition review.

Can organizations submit multiple applications?

Yes, if scientifically distinct. NIH policy still blocks overlapping applications under review and disallows certain duplicative submission patterns until summary statements clear, so sequencing matters.

Red flags to flag before submission

• If your milestones are aspirational only and not measurable.
• If your budget rationale is not tied to phase-specific activities.
• If the transition rationale assumes continuation regardless of outcomes.
• If your PI team is strong technically but the project lacks commercialization and regulatory realism.
• If registration is incomplete at submission time.

Official links and next actions

Use these links directly from the official source pages:

• Official NOFO page: https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-26-019.html
• NIH grants how to apply guide: https://grants.nih.gov/grants/how-to-apply-application-guide
• Grants.gov: https://www.grants.gov
• eRA Commons: https://public.era.nih.gov
• NIH Grants Policy Statement: https://grants.nih.gov/grants/policy/policy
• NIH application support portal: https://www.era.nih.gov/need-help
• Opportunity notices and policy updates referenced in the NOFO (for example NOT-OD-26-029)

Quick action plan for 2026/27 applicants

1. Confirm your organization and PI roles in NIH systems now, not during submission week.
2. Create a split R61/R33 concept note.
3. Draft milestones as measurable gates and not generic outputs.
4. Prepare the required IP and Regulatory Strategies.pdf attachment early.
5. Build a transition package template for R61-to-R33 conversion.
6. Submit early in your target cycle and keep a correction window.

If your project can survive the first 12 months with reproducible feasibility data and clear decision gates, this NOFO is one of the strongest early translational paths in the NIH HLBS space for devices, diagnostics, and tools.