Enabling Technologies to Accelerate Development of Oral Biodevices (R01 Clinical Trial Not Allowed) | RFA DE 19 009

Opportunity Information: Apply for RFA DE 19 009

The Enabling Technologies to Accelerate Development of Oral Biodevices (R01 Clinical Trial Not Allowed) funding opportunity (RFA-DE-19-009) is an NIH discretionary grant program focused on speeding up the creation and clinical translation of intraoral biodevices. The emphasis is on transformative engineering solutions that overcome practical technical barriers in this space, either by developing entirely new technologies or by substantially optimizing and advancing existing approaches so they are closer to real-world clinical use. While the work should be clinically relevant and clearly aimed at eventual patient impact, the FOA explicitly does not allow clinical trials under this mechanism, so the expected endpoint is strong preclinical evidence rather than testing in humans.

At its core, the FOA targets oral biodevices that can be used in the mouth (intraoral) to support precision medicine approaches for both oral and broader systemic health. The applications span detection, diagnosis, and treatment of disease, as well as tools for measuring patient functional status and assessing clinical outcomes. In practical terms, NIH is looking for devices or device platforms that could plausibly become part of routine care, for example by enabling more personalized monitoring, earlier detection of disease signals, or targeted interventions that can be delivered and tracked directly within the oral environment.

A major technical theme of the FOA is integration: applicants are encouraged to propose engineering approaches that successfully combine electronic, physical, and biological systems into a single functional biodevice. That means the program is not just interested in isolated sensor concepts or materials in a lab setting, but in integrated systems that can operate safely and effectively in the complex conditions of the mouth (saliva, mechanical forces from chewing, microbial biofilms, temperature changes, and long-term wear considerations). Competitive projects are expected to confront real constraints such as biocompatibility, stability, robustness, miniaturization, power and data handling, signal quality in a noisy environment, user comfort, and pathways toward manufacturability and clinical usability.

The expected research products are functional biodevices and integrated technology approaches that are thoroughly characterized to demonstrate preclinical safety and effective performance tied to a specific intended clinical application. In other words, the deliverable is not just an early prototype, but a well-validated device or system with rigorous testing data that supports a credible next step toward clinical translation. The FOA framing suggests that strong proposals will define a clear use case, identify the engineering bottlenecks preventing that use case today, and provide a development and validation plan that shows the device can meet performance requirements and safety expectations before any human testing.

Because these devices sit at the intersection of multiple disciplines, the FOA strongly encourages interdisciplinary collaborations. It explicitly calls out teams that bridge engineering with multifunctional sensors, pharmacology, chemistry, medicine, and dentistry, and it also encourages partnerships between academia and industry. The intent is to move beyond siloed development so that the resulting technologies are not only scientifically interesting, but also practical, clinically informed, and aligned with real translational pathways (including considerations like deployment workflow, regulatory expectations for safety and performance, and potential scalability).

On eligibility, the opportunity is broad and includes many U.S.-based organizational types such as state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is constrained. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined in the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant may include certain foreign collaborations or elements when well-justified and compliant with NIH policy.

Administratively, the sponsor is the National Institutes of Health, the mechanism is an R01 grant, the activity category is Health, and the CFDA number listed is 93.121. The original closing date shown is 2019-03-13 and the FOA creation date is 2018-11-15, indicating this is a specific published cycle rather than an open-ended standing program. The award ceiling and expected number of awards are not specified in the provided source data, so budgets and award volume would typically be governed by NIH R01 norms and the details in the full FOA and related NIH policy documents.

Overall, this FOA is aimed at teams that can demonstrate genuine engineering innovation and a credible translational plan, culminating in a preclinically validated intraoral biodevice platform with a clear intended clinical application in precision detection, diagnosis, treatment, or patient status/outcome measurement, without conducting clinical trials within the project period.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Enabling Technologies to Accelerate Development of Oral Biodevices (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2018-11-15.
• Applicants must submit their applications by 2019-03-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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