Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional
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 generations of devices.
In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development.
As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 81 4. 3(s)).
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 generations of devices.
In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development.
As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 81 4. 3(s)).
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $61,000,000
Office: Food and Drug Administration
Estimated Funding: $61,000,000
Who's Eligible
Obtain Full Opportunity Text:
FULL ANNOUNCEMENT
Additional Information of Eligibility:
Governments State Governments Indian/Native American Tribal Governments (Federally Recognized) U. S. Territory or Possession This opportunity is only available to the following State, Tribal or Territorial food safety programs: Manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs), or those that meet the eligibility requirements and agree to enter into a food safety inspection contract with FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement.
Competition is limited to State, Tribal and Territorial manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.
Applicants will be categorized under one of two funding tracks: MFRPS Development or MFRPS Maintenance (see eligibility criteria below).
Within each funding track, an applicant may apply to additional funding options for which they meet the eligibility criteria (below).
The applicant must hold a nonpublic information sharing agreement with FDA pursuant to 20 CFR §20.88 (“20.88 agreement”) or agree to enter into a 20.88 agreement with FDA by the end of grant year one (June 30, 2024).
Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction’s needs both in terms of amounts of funding and number of project years.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-024.html
Contact:
Agency Email Description:
shashi.malhotra@fda.hhs.gov
Agency Email:
Date Posted:
2023-01-25
Application Due Date:
Archive Date:
2023-04-28
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