Pediatric Device Consortia Grants Program (P50) | RFA FD 18 004

Opportunity Information: Apply for RFA FD 18 004

The Pediatric Device Consortia Grants Program (P50) is a cooperative agreement funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), designed to strengthen the pipeline of medical devices intended for children and young people. The core purpose of the program is to help move pediatric medical devices from early ideas to real-world use by facilitating their development, production, and distribution. Even though the program is administered through the FDA's Office of Orphan Products Development, the scope is not limited to rare diseases; it explicitly covers devices for all pediatric diseases and conditions.

Under this opportunity, applicants are expected to operate as a nonprofit consortium that supports pediatric device innovators (such as inventors, clinicians, engineers, startups, and other developers) by providing expert advice and hands-on support services. The support is meant to span the entire medical device "total product life cycle." In practical terms, that includes early concept and design work, pre-market development activities (like engineering refinement, regulatory strategy, clinical planning, and quality systems), and steps toward commercialization and broader adoption. The program also recognizes that device development does not stop at first market entry, so it anticipates that consortia will help innovators plan for product iteration, including the transition to subsequent generations of devices as technology improves and clinical needs evolve.

A notable emphasis of the program is evidence generation for pediatric devices, including guidance on how to build credible data packages that demonstrate safety, effectiveness, and real-world performance. The FOA specifically highlights real world evidence, signaling that consortia should be able to advise on how to use data from clinical practice, registries, electronic health records, and other real-world sources to complement traditional studies where appropriate. This focus reflects the reality that pediatric device studies can be uniquely challenging due to smaller patient populations, ethical and logistical constraints, growth-related anatomical changes, and differences in physiology across pediatric age groups.

For eligibility and population coverage, the FOA defines the pediatric population for medical device purposes as individuals younger than 22 years of age, meaning from birth through age 21 (up to, but not including, the 22nd birthday) at the time of diagnosis or treatment. That definition intentionally captures neonates, infants, children, and adolescents, and it underscores that the consortium should be prepared to address device needs across a wide developmental range, from very small neonatal applications to devices used in older adolescents and young adults still considered pediatric under this program.

Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, which generally implies an active partnership between the FDA and award recipients rather than a purely hands-off grant. The opportunity is listed under CFDA 93.103 and falls within consumer protection and health. Eligible applicants include a broad mix of public and private entities, such as state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; and nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories). The funding opportunity (RFA-FD-18-004) was created on January 16, 2018, with an original closing date of March 7, 2018. The award ceiling is $1,500,000, and the FDA anticipated making about five awards, indicating an intent to support multiple consortia capable of serving as regional or national hubs for pediatric device expertise and developer support.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health sector is offering a public funding opportunity titled "Pediatric Device Consortia Grants Program (P50)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Jan 16, 2018.
• Applicants must submit their applications by Mar 07, 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 $1,500,000.00 in funding.
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), 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.

Apply for RFA FD 18 004

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