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Pediatric Device Consortia Grants Program (P50)
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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $6,000,000
Office: Food and Drug Administration
Estimated Funding: $6,000,000
Who's Eligible
Obtain Full Opportunity Text:
Link to full announcement RFA-FD-18-004
Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession.
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-18-004.html
Contact:
Agency Email Description:
daniel.lukash@fda.hhs.gov
Agency Email:
Date Posted:
2018-01-16
Application Due Date:
Archive Date:
2018-04-06
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