NEPDC Eligibility Requirements
- Consideration will only be given to applications submitted electronically through the NEPDC web-based submission system.
- Grant Applications are accepted by invitation only based on results of Abstract review. Abstracts may be submitted at any time using the NEPDC web-based submission system.
- Grant Applications will be evaluated quarterly following the posted review schedule.
- Award eligibility is restricted to concepts classified as pediatric medical devices. To verify your device eligibility, refer to Federal Food Drug & Cosmetic Act section 201(h) section.
- Applicants who have received consultation on their device from other FDA-funded Pediatric Device Consortium members must provide a description of all prior interactions when applying for Pre-Seed, Seed, or Target Challenge awards.
- Applicants who have received monetary grants for their device from other FDA-funded Pediatric Device Consortium are not eligible for Pre-Seed, Seed, or Target Challenge awards.
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible for Pre-Seed, Seed, or Target Challenge awards.
NEPDC Confidentiality Agreement
- NEPDC agrees to keep all materials submitted and marked ”confidential“ confidential for a period of one year.
- NEPDC requires any individual reviewing your application to keep your materials confidential.
- NEPDC requires reviewers to recuse themselves from the review if they have a conflict of interest as defined by the NIH here.
- NEPDC may use the submitter‘s name, the submitter‘s institution, the project name and the project description for NEPDC‘s internal tracking and record keeping as well as to comply with reporting requirements mandated by the FDA or other government agencies.
Application Terms and Conditions
- NEPDC reserves the right to use technology, product, and company names as well as photographs, illustrations, and diagrams of all publicly disclosed client materials for documentation, reporting and marketing purposes.
- NEPDC acknowledges that the submission of this application does not grant NEPDC any rights to the work and the work and any accompanying intellectual property is owned by the applicant.
- The submitter acknowledges that material submitted for review by NEPDC for which the submitter requests funding or in-kind service is their own work or is submitted with permission from the entity that has legal rights to the material.
- Indirect costs for institutional overhead may be supported by NEPDC funding to a maximum of 8% of direct costs.
- At the conclusion of the project period (specified in the grant award letter), a final report must be submitted to the NEPDC Director
- Recipients of NEPDC funding and/or in-kind service agree to provide annual development updates for a period up to 5 years following completion of the project period.
- Any public disclosure of work product resulting from NEPDC support (e.g. publications, presentation, press release, web site, etc.) must include a disclaimer such as ”This project was supported by the New England Pediatric Device Consortium (NEPDC) which is part of the FDA Pediatric Device Consortia Grant Program (FDA P50FD004907). The content is solely attributed to the authors and does not necessarily represent the official views of the NEPDC or FDA.“
- Please note that none of the funds from this grant can be used for research involving human subjects or identifiable data without prior approval from an Institutional Review Board (IRB). If applicable, grantees must supply NEPDC with all approval documents.