Notice Number: NOT-FD-18-002
Key Dates
Release Date: October 11, 2017
Estimated Publication Date of Announcement: November 15, 2017
First Estimated Application Due Date: March 1, 2018
Earliest Estimated Award Date: September 1, 2018
Earliest Estimated Start Date: September 1, 2018
None
Issued by
U.S. Food and Drug Administration (FDA)
Purpose
The U.S. Food and Drug Administration, Office of Orphan Products Development intends to publish a Funding Opportunity Announcement (FOA) to solicit grant applications from nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. While the consortia are non-profit entities, their contacts and membership can include for-profit partners.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in November 2017 with an expected application due date in March 1, 2018.
This FOA will utilize the P50 activity code. Details of the planned FOA are provided below.
Research Initiative Details
The intended outcome of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA will be issued by the 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. The pediatric population (neonates, infants, children, and adolescents) for medical devices is defined as patients who are age younger than 22 years at the time of their diagnosis or treatment (that is, from birth through the twenty-first year of life not including the twenty-second birthday).
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 such as understanding the evolution of medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generation of devices.
Applicants shall demonstrate their ability to perform the following:
(1) Encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
(2) Mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
(3) Connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
(4) Assessing the scientific and medical merit of proposed pediatric device projects;
(5) Providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and
(6) Providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.
Applicants should have experience in regulatory, business planning, and device development services (e.g., intellectual property advising, engineering, laboratory and animal testing, grant writing, clinical trial design, etc.).
The consortia are expected to be knowledgeable and provide advice and/or projects related to leveraging real-world evidence within the pediatric medical device ecosystem. FDA has published guidance on "Use of real-world evidence to support regulatory decision-making for medical devices." This guidance can be found at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf. The consortia will be asked to work with the Medical Device Innovation Consortium which has established the National Evaluation System for health Technology Coordinating Center (NESTcc) to further the development of methods of evidence generation and data use to support real-world evidence.
Applicants will be required to demonstrate how to access various Federal and non-Federal funding resources.
The grants are available to any domestic, public or private, nonprofit entity (including State and local units of government). Federal agencies may not apply.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Dan Lukash
Office of Acquisitions and Grant Services
U.S. Food and Drug Administration (FDA)
Telephone: 240-402-7596
Email: daniel.lukash@fda.hhs.gov
Eric Chen
Office of Orphan Products Development
U.S. Food and Drug Administration (FDA)
Telephone: 301-796-6327
Email: eric.chen@fda.hhs.gov
and Human Services (HHS)
