Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R43 - Clinical Trials Optional) | RFA DA 26 016

Opportunity Information: Apply for RFA DA 26 016

The Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R43 - Clinical Trials Optional) opportunity is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement focused on early-stage research and development of medical devices intended specifically for children, adolescents, and young adults impacted by substance use and addiction. The targeted age range is 0 through 21 years old, consistent with how the FDA Center for Devices and Radiological Health defines the pediatric population. In practical terms, the NOFO is looking for small businesses to propose device-based solutions that are clearly indicated for pediatric use in the context of substance use disorders and addiction-related needs, rather than general-purpose devices that only incidentally could be used in younger patients.

The funding mechanism is an R43, which corresponds to the SBIR Phase I grant. Phase I awards are generally meant to establish feasibility, demonstrate proof of concept, and reduce technical risk so that a device concept is ready for further development and eventual commercialization. The NOFO states that clinical trials are optional, meaning applicants may propose studies that do not involve a clinical trial (for example, benchtop validation, usability engineering, design verification activities, preclinical testing, or prototype development), or they may include a clinical trial if it is appropriate for the maturity of the technology and the specific aims. The activity area is categorized under Education and Health, and the program is associated with CFDA number 93.279, which aligns with NIH substance use and addiction research portfolios.

Eligibility is limited to small business concerns, which is standard for SBIR. The announcement is also clear about restrictions related to foreign participation: non-U.S. (foreign) organizations cannot apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply. That said, the notice indicates that foreign components, as defined in the NIH Grants Policy Statement, may be allowed. In NIH terms, that typically means a U.S.-based applicant organization can sometimes include a discrete element of the project that will be performed outside the United States if it is well-justified, clearly described, and allowable under NIH policy, but the applicant organization itself must be eligible and U.S.-based.

Key administrative details include the funding opportunity number RFA-DA-26-016 and an original application due date (closing date) of February 26, 2025. The award ceiling listed is $400,000, which signals the maximum award amount expected under this announcement for a single award, though actual budgets generally need to be tightly matched to the proposed Phase I scope and the specific milestones. The posting indicates an expected awards field but does not provide a number here, so applicants should not assume a particular payline or volume of awards based on the excerpt alone. The opportunity was created on November 21, 2024, which provides context for when the solicitation entered circulation.

Overall, this NOFO is best read as a targeted call for pediatric-focused device innovation addressing substance use and addiction, using the SBIR Phase I framework to support feasibility-stage R&D. Strong applications will typically make the pediatric indication central (not an afterthought), articulate the specific addiction-related problem being addressed in a pediatric population, describe a credible development plan and technical approach suitable for Phase I, and lay out how the work will position the device for the next stage of development and eventual deployment in real-world pediatric care settings.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R43 - Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2025-02-26. (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 $400,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA DA 26 016

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