The goal of the FDA’s Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.
FDA funds consortia that provide expert advising and support services to innovators of children's devices. These services include business and regulatory consulting, as well as device testing capabilities.
Specific areas of expertise provided by the consortia include intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design.
A successful PDC brings together individuals and institutions that can support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. The consortia are expected to support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing.
To accomplish this work, the consortia unite individuals, groups, or institutions to provide the following capabilities: knowledge of the clinical needs for pediatric devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.
This program is intended to further the development of multiple pediatric medical devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases.
The FDA definition of “pediatric”, for purposes of device development, encompasses devices used for patients who are 21 years of age or younger at the time of diagnosis or treatment.
The FDA’s Center for Devices and Radiological Health, defines “pediatric use” as any use of a medical device in a pediatric population in which there is a primary pediatric indication OR a more general indication where considerable pediatric application is anticipated.