Pediatric Device Consortia Grant Program (P50) | Apply Online

Opportunity Summary:

The Pediatric Device Consortia Grant Program (P50), funded by the U.S. Food and Drug Administration (FDA) through the Office of Orphan Products Development (OOPD), is designed to speed up and strengthen the pipeline of medical devices made specifically for children. Rather than paying for a single product to be built, the program funds nonprofit consortia that can support many pediatric device projects at once by providing hands-on expertise, infrastructure, and coordinated services to innovators. The overall aim is to make it easier for promising pediatric device ideas to move from concept to development, testing, regulatory clearance pathways, and ultimately production and distribution.

A key point of this opportunity is that the applicants are expected to be nonprofit consortia, but they are not required to operate in isolation from industry. While the consortia themselves must be nonprofit entities, they can include partnerships and participation from for-profit companies, clinicians, engineers, manufacturers, investors, and other stakeholders who can help move pediatric device innovation forward. The FDA is essentially investing in a support ecosystem: a consortium that can repeatedly guide inventors and small companies through the technical, clinical, business, and regulatory hurdles that often slow pediatric devices more than adult devices.

The services the consortium provides are central to the grant. The FDA expects consortia to deliver expert advising and practical support to children’s device innovators, including business consulting (such as commercialization planning, reimbursement strategy considerations, market analysis, and funding readiness), and regulatory consulting (such as pathway planning, pre-submission strategy, quality system considerations, and general navigation of FDA device requirements). The program also emphasizes device testing capabilities, meaning the consortium should be able to help innovators access or conduct relevant testing services (for example, engineering verification, bench testing, safety assessments, prototyping support, or connections to labs and facilities). In other words, the consortium is expected to be a capable hub that reduces friction for multiple device teams, not simply a networking group.

Although the grant is administered under the FDA office that historically deals with orphan products, the scope here is broader than rare diseases. The opportunity explicitly states that it is intended to encompass devices for all pediatric conditions and diseases, not only rare conditions. The pediatric population is defined broadly as patients 21 years of age or younger at the time of diagnosis or treatment, and it includes neonates, infants, children, and adolescents. That definition matters because pediatric device needs vary significantly across these age groups, and consortia are expected to understand and address those differences when advising innovators.

From a funding and administrative standpoint, this is a discretionary grant opportunity (Funding Opportunity Number RFA-FD-13-010) with an estimated total program funding level of $3,000,000 and an expectation of about five awards. Individual awards have an anticipated ceiling of $750,000 and a floor of $250,000, and there is no cost-sharing or matching requirement. The listing is associated with CFDA number 93.103 (Food and Drug Administration Research). Key dates in the posted announcement included a posted/creation date of March 19, 2013, and an application closing date of June 2, 2013, with an archive date of July 2, 2013.

Eligibility is broad in the sense that multiple types of organizations can apply, including state and local governments, tribal governments and tribal organizations, special district governments, public and private institutions of higher education, and nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits, with details referenced in the full announcement). The notice also encourages applications from a range of higher-education institutions, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). This reflects an intent to build strong, diverse regional or national consortia that can connect clinical needs, engineering expertise, and commercialization resources.

In practical terms, a strong applicant for this program is typically an established consortium or an organization capable of operating like one: coordinating subject-matter experts, maintaining a structured intake and review process for device projects, offering repeatable advisory services, and demonstrating the ability to support several pediatric device efforts concurrently. Because the program is not meant to fund one device, the proposal needs to show how the consortium will identify, prioritize, and assist a portfolio of device innovators over the project period, and how it will measure success in moving multiple pediatric devices closer to real-world use.

For reference and support, the opportunity points applicants to the NIH Guide for Grants and Contracts for additional information and provides a grants management contact at FDA: Vieda Hubbard, Grants Management Specialist (301-827-7177, vieda.hubbard@fda.hhs.gov), for access or application-related issues.

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