Safe and Effective Devices for Use In Neonatal, Perinatal and Pediatric Care Settings (R43/R44 Clinical Trial Optional) | RFA HD 19 001

Opportunity Information: Apply for RFA HD 19 001

The grant opportunity titled "Safe and Effective Devices for Use In Neonatal, Perinatal and Pediatric Care Settings (R43/R44 Clinical Trial Optional)" (Funding Opportunity Number: RFA HD 19 001) is a Small Business Innovation Research (SBIR) funding announcement from the U.S. Department of Health and Human Services, National Institutes of Health. It sits in the health-focused assistance area (CFDA 93.865) and is structured as a discretionary grant program aimed specifically at small business applicants. The central purpose is to move practical medical device innovation forward for some of the most sensitive clinical environments: neonatal, perinatal, and pediatric care, where patients range from fetuses and newborns to infants, children, and adolescents, and where safety and accuracy requirements are especially demanding.

At its core, this FOA is trying to bridge two worlds that often develop in parallel: the clinical community that understands real bedside needs and constraints, and the bioengineering and device-development community that can translate those needs into workable tools. The program explicitly encourages collaboration between clinicians and engineers to ensure that the devices being created or improved are not only technically sophisticated, but also usable and reliable in day-to-day care settings. The emphasis on "safe, accurate, and effective" reflects the reality that pediatric and neonatal patients can be more vulnerable to device-related risks, measurement errors, and workflow disruptions than typical adult populations, so innovations must be carefully designed and validated for these settings.

The devices supported under this opportunity may be entirely new products or meaningful improvements to devices that already exist. The scope is broad in terms of development stage: projects can span from early concept and feasibility work through more advanced development and testing. Importantly, the FOA signals that projects should not stop at proof-of-concept in a lab sense; they should be designed to progress toward real-world clinical utility. The "Clinical Trial Optional" designation indicates that applicants may propose studies that include clinical trials if appropriate, but a clinical trial is not automatically required for every project. This flexibility allows companies to propose the right kind of evidence-generation strategy for their stage of development, whether that is benchtop testing, usability studies, validation work, or clinical evaluation.

A defining feature of the announcement is its strong commercialization expectation. Applicants are expected to lay out a clear plan that explains how the proposed device will be translated into a product that healthcare providers can actually adopt in routine clinical care for the target population. In other words, the program is not just funding research for research's sake; it is looking for development efforts that have a credible path toward market entry and sustained use, including the practical considerations that come with medical devices such as manufacturability, regulatory strategy, clinical adoption, and fit within pediatric and neonatal care workflows. The overall framing makes it clear that the end goal is deployment in regular clinical care settings, not limited demonstration use.

From an administrative standpoint, the opportunity was created on March 5, 2018, with an original closing date of August 1, 2018. The award ceiling listed is $225,000, and the agency expected to make around five awards. Taken together, those details suggest a targeted, competitive SBIR solicitation designed to seed a small set of high-potential device-development projects, each with a defined budget cap and a focus on generating actionable progress toward a viable pediatric, perinatal, or neonatal medical device solution.

• The Department of Health and Human Services, National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Safe and Effective Devices for Use In Neonatal, Perinatal and Pediatric Care Settings (R43/R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on Mar 05, 2018.
• Applicants must submit their applications by Aug 01, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: Small businesses.

Apply for RFA HD 19 001

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