FDA’s Preliminary FOA

FDA https://www.fda.gov has issued a preliminary posting for a Funding Opportunity Announcement (FOA) (RFA-FD-18-004) for the “Pediatric Device Consortia Grants program (P50). Interested applicants must apply through www.grants.gov when the formal FOA is expected to be posted shortly. No applications will be accepted through this preliminary posting.

The goal is to help the development, production, and distribution of pediatric medical devices by issuing funding for a nonprofit consortia. Although the FOA is going to be issued by FDA’s Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions and not devices for just rare diseases.

Applicants will request funding to serve as a non-profit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services offered will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and in some cases replacement by subsequent generation of devices.

In addition, the consortia should also provide expertise on evidence generation, including the use of real world evidence for pediatric device development.

The grants are available to any domestic, public or private nonprofit entities including State and local units of government. The FDA/Office of Orphan Products Development intends to fund up to $6,000,000 for fiscal year 2018 in support of this grant program. Of the estimated $6,000,000 approximately $1,000,000 may be used for RWE Demonstration Project funding. It is anticipated up to five awards will be made.

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