FDA funds consortia which 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 Pediatric Device Consortium 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 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 goal of the FDA’s PDC Grant Program is to support the development of nonprofit consortia designed to stimulate projects which will promote pediatric device development.

The consortia will facilitate the development, production, and distribution of pediatric medical devices by:

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;

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, and post-marketing needs; and

6. 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.

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.

In FY18, FDA has awarded five grants totaling up to $6 million per year over the next five years to various Pediatric Device Consortia (PDC) to enhance the development, production and distribution of pediatric medical devices that will provide advice and support services to innovators of children's devices. The program has awarded $37 million to various consortia since 2009. The amount of funding awarded in future years will depend on annual Congressional appropriations.