Pediatric Device Consortia Grants Program (P50)

Funding Opportunity ID: 300115
Opportunity Number: RFA-FD-18-004
Opportunity Title: Pediatric Device Consortia Grants Program (P50)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Consumer Protection
Category Explanation:
CFDA Number(s): 93.103
Eligible Applicants: 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
Additional Information on Eligibility:
Agency Code: HHS-FDA
Agency Name: Department of Health and Human Services
Food and Drug Administration
Posted Date: Jan 16, 2018
Close Date: Mar 07, 2018
Last Updated Date: Jan 16, 2018
Award Ceiling: $1,500,000
Award Floor: $0
Estimated Total Program Funding: $6,000,000
Expected Number of Awards: 5
Description: The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA’s Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generation of devices. In addition, consortia should also provide expertise on evidence generation, including use of real world evidence, for pediatric device development. The pediatric population (i.e., neonates, infants, children, and adolescents) for medical devices is defined as individuals who are younger than 22 years of age (that is, from birth through the twenty-first year of life not including the twenty-second birthday) at the time of diagnosis or treatment.
Version: 1

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