What is the Pediatric Device Consortia (PDC) Grants Program?
The goal of the FDA’s PDC Grants Program is to facilitate the development, production, and distribution of pediatric medical devices. FDA will provide grants to consortia to provide expertise and support services to innovators of pediatric medical devices that will either result in, or substantially contribute to, market approval of these devices. The PDC Grants Program is administered by the Office of Orphan Products Development (OOPD).
Who may apply for a PDC Grant?
PDC grants are available to any domestic, public or private, nonprofit entity, including State and local units of government. Both non-academic and academic centers are encouraged to apply for this program. Federal agencies may not apply. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.
How can I learn more about the PDC Grant Program?
The preliminary Funding Opportunity Announcement (FOA) for the 2018 Grants Cycle can be found at the following link. Click here
What defines Pediatric and Pediatric Use?
The FDA definition of “pediatric” for purposes of device development 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.
The FDA’s Center for Devices and Radiological Health, defines “pediatric use” to be any use of a medical device in a pediatric population, as defined above, in which there is a primary pediatric indication. General indications, where considerable pediatric application is anticipated, are also included in this definition.
To view the Premarket Assessment of Pediatric Medical Devices guidance, click here.
What are the Objectives of the PDC Grant Program?
The goal of the PDC Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of non-profit consortia. These non-profit consortia provide a platform of experienced regulatory, business planning, and device development services (such as but not limited to intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design) to help foster and guide the advancement of medical devices for pediatric patients.
The consortia facilitate the development, production, and distribution of pediatric medical devices by:
- Encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
- Mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
- 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;
- Assessing the scientific and medical merit of proposed pediatric device projects;
- 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
- Providing regulatory consultation to device sponsors in support of the submission of an application (e.g., pre-submission, investigational device exemption, premarket notification [510(k)], premarket approval, humanitarian device exemption, etc.) for pediatric devices.
How much money is available for PDC Grant Program Grants?
The anticipated annual budget for funding new grants is $6.0 million for FY 2018. The actual amount of funding will depend on annual appropriations.
When are applications Due?
Applications are due March 16, 2018, by 11:59 PM Eastern Time.
How are applications submitted
Applications must be submitted through Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.
What are the criteria for review?
Criteria for review are currently discussed in the preliminary posting of the FOA.
Who can I contact for questions concerning the budget of my potential grant application?
Questions regarding financial aspects of a proposed application should be addressed to Daniel Lukash, Office of Acquisitions & Grant Services, 5630 Fishers Lane (HFA-500), Room 2034, Rockville, MD 20857, 301-827-7177, e-mail: Daniel.Lukash@fda.hhs.gov
Who can I contact for questions regarding the research/clinical protocol sections of my potential grant application?
Scientific and Research questions should be addressed to Eric Chen, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Avenue (WO 32-5295), Silver Spring, MD 20993-0002, e-mail: Eric.Chen@fda.hhs.gov