The U.S. Food and Drug Administration (FDA) has awarded grants to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices.
Legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit consortia to help stimulate projects to promote the development and availability of pediatric medical devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012 and again in the FDA Reauthorization Act of 2017 to run through fiscal year 2022. The program aims to enhance the development, production and distribution of pediatric medical devices and has awarded $37 million to various consortia since 2009.
The PDC Grants Program was launched in 2009, and 2018 is the fourth time the FDA has awarded grants. Each group’s grant runs for five consecutive years. Funding for fiscal year 2018 is approximately $1 million to $1.35 million per consortium. Support for the four additional years will be contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
The consortia have assisted or advised more than 1,000 medical device projects since the program began. As of September 12, 2018, there are now 19 pediatric medical devices available to patients as a result of the PDC grants program, including a needle-free blood collection device that attaches to peripheral IV systems for use as a direct blood draw device; a surgical vessel sealing system for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles and a rapid infusion device that delivers fluids to a patient’s vascular system.
The five PDC grant recipients and their principal investigators for 2018 are:
This information was adapted from fda.gov
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.