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National Capital Consortium for Pediatric Device Innovation 2.0

Award Number: P50FD006430
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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National Capital Consortium for Pediatric Device Innovation 2.0 - ABSTRACT NCC-PDI’s mission is to facilitate the development and commercialization of devices that are indicated for use in pediatric patients or that are intended to treat, diagnose, or cure diseases from which pediatric patients suffer. The Consortium has served as an accelerator to medical device innovators that intend to label their device for use, in the United States, in the general pediatric population or a subpopulation. The Food and Drug Administration’s report to Congress on “FY 2016 Premarket Approval of Pediatric Uses of Devices” indicates that over a 9-year period (2008-2016), an average of almost nine devices were approved per year that were indicated for pediatric patients; this equated to an average of 20.5 percent Pre-market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) over this time. This represents a formidable progress that was achieved thanks in large to the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. A closer look at the data, however, suggests that the majority of these approved devices are labeled for the adolescent subpopulation (12 years through 21 years of age) in addition to older adults. There still remains a significant unmet need for devices labeled for subpopulations of neonates (birth until 1 month of age), infants (1 month until 2 years of age), and children (2 years until 12 years of age). NCC-PDI’s long-term goal under this RFA is to contribute to the national effort to address this gap and help bring more devices to market. Our short-term and operational goals are to continuously enhance our capabilities in providing expert advising and support services to innovators of pediatric medical devices, focusing on the total product life cycle for medical devices from concept, through pre-market development, to commercialization. We will reach our long-term and short-term goals by achieving the following specific aims. Specific Aim 1. Enhance the pipeline of high-growth pediatric device entrepreneurs with special considerations given to those who focus on the unmet needs of subpopulations of neonates, infants, and children. Specific Aim 2. Foster the advance of pediatric medical devices through access to a platform of experienced business, regulatory, reimbursement, medicine & science, engineering & prototyping, and trials design. Specific Aim 3. Through implementation of demonstration projects, develop, verify and operationalize methods of evidence generation and data usage, and demonstrate scalability across diverse devices and diseases. Our Consortium consists of lead members (Children’s National Health System and University of Maryland), members (BioHealth Innovation, MedTech Innovator, HealthCore/NERI, and Resnick, Chodorow, & Associates), and extended members (Smithwise, Cadence, I-ACT, PEDSnet, Bear Institute/Cerner, Digital Infuzion, Epidarex, Medical Murray, SFA Regulatory, CTSI-CN, CALCE, M-CERSI).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	5	7/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	5	8/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,150,000 )
2022	2022	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	5	8/16/2022	SUPPLEMENT FOR EXPANSION	$150,000
2022	2022	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	5	8/10/2022	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,150,000

Issue Date FY: 2021 ( Subtotal = $1,150,000 )
2021	2021	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	4	8/13/2021	SUPPLEMENT FOR EXPANSION	$150,000
2021	2021	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	4	8/11/2021	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,150,000

Issue Date FY: 2020 ( Subtotal = $1,150,000 )
2020	2020	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	003	3	8/28/2020	NON-COMPETING CONTINUATION	$0
2020	2020	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	002	3	8/27/2020	SUPPLEMENT FOR EXPANSION	$150,000
2020	2020	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	3	8/25/2020	NON-COMPETING CONTINUATION	$1,000,000
2020	2019	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	2	2/28/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,150,000

Issue Date FY: 2019 ( Subtotal = $1,000,000 )
2019	2019	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	2	8/27/2019	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	8/23/2018	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $5,450,000

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National Capital Consortium for Pediatric Device Innovation 2.0

Award Number: P50FD006430

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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