Enabling Technologies to Accelerate Development of Oral Biodevices (R21 Clinical Trial Not Allowed) | RFA DE 19 008

Opportunity Information: Apply for RFA DE 19 008

The grant opportunity "Enabling Technologies to Accelerate Development of Oral Biodevices (R21 Clinical Trial Not Allowed)" is an NIH exploratory/developmental funding announcement focused on pushing intraoral biodevices closer to real-world clinical use. It is designed for early-stage, high-impact engineering work that tackles the key technical roadblocks that have been slowing progress in this area. The goal is not incremental improvements for their own sake, but transformative or substantially optimized approaches that meaningfully improve how oral biodevices can be built, integrated, validated, and ultimately translated toward patient care.

A central theme of the announcement is the development of engineering solutions that enable safe, effective, functional devices that operate inside the mouth, a setting that is mechanically demanding and biologically complex. Proposed projects are expected to address challenges involved in integrating electronic, physical, and biological systems into practical intraoral platforms. In plain terms, the NIH is looking for technologies that can reliably function in the oral environment while maintaining performance, durability, biocompatibility, and safety, and while generating clinically relevant data or delivering clinically relevant actions. The intended applications span detection, diagnosis, and treatment of oral diseases, and also extend to systemic health conditions where oral measurements can provide useful information. The opportunity also highlights precision medicine goals, meaning devices and sensors that can support more individualized assessment and care, potentially through biomarkers or patient-specific measurements. Another emphasized application area is measurement of patient functional status and clinical outcome assessment, which points to devices that can quantify meaningful patient-centered metrics rather than only generating raw sensor signals.

The expected outputs from funded projects are tangible, enabling products such as proof-of-concept prototype oral biodevices, specialized biosensors, and core supporting technologies that can be reused or adapted across multiple device concepts. The FOA is framed around accelerating development, so applicants are implicitly encouraged to propose work that demonstrates feasibility and de-risks a pathway toward later-stage development, rather than stopping at theoretical modeling alone. At the same time, because the mechanism is an R21 and the FOA explicitly states "Clinical Trial Not Allowed," the supported work is intended to remain preclinical and developmental, focusing on prototype creation, bench testing, validation in relevant non-clinical settings, and engineering optimization rather than formal clinical trials in human participants as defined by NIH policy.

This funding opportunity strongly encourages interdisciplinary collaboration, reflecting the reality that successful oral biodevices sit at the intersection of multiple fields. The FOA calls out collaborations across engineering, multifunctional sensors, pharmacology, chemistry, medicine, and dentistry, and it specifically welcomes partnerships between academia and industry. That emphasis signals that reviewers will likely value teams that combine deep technical device expertise with a clear understanding of oral biology, clinical requirements, and translational constraints such as manufacturability, usability, and safety considerations that matter for eventual clinical deployment.

Administratively, the opportunity is an NIH discretionary grant under CFDA 93.121, with the Funding Opportunity Number RFA-DE-19-008 and an original closing date of March 19, 2019 (with a creation date of November 15, 2018). The award ceiling listed is $200,000. Eligibility is broad and includes many U.S.-based applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly notes eligibility interest in a range of institutional categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions. On the foreign involvement side, non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components (as defined by NIH policy) are allowed, which typically means a U.S. applicant may include certain well-justified foreign elements within the project while remaining a U.S.-led application.

Overall, this FOA is best understood as a targeted push to create the enabling building blocks and prototype demonstrations that can make intraoral biodevices practical, clinically meaningful, and ready for the next step of translation. It prioritizes integrated systems engineering in the challenging oral environment, clinically relevant sensing or therapeutic functionality aligned with precision medicine, and collaborative, cross-disciplinary development aimed at producing real prototype technologies rather than purely conceptual advances.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Enabling Technologies to Accelerate Development of Oral Biodevices (R21 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 2019-03-19. (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 $200,000.00 in funding.
• 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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