High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
Almond
Christopher S D
CS
Department of Cardiology, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.
Chen
Eric A
EA
Berman
Michael R
MR
Less
Joanne R
JR
Baldwin
J Timothy
JT
Linde-Feucht
Sarah R
SR
Hoke
Tracey R
TR
Pearson
Gail D
GD
Jenkins
Kathy
K
Duncan
Brian W
BW
Zuckerman
Bram D
BD
D002648:Child; D002986:Clinical Trials as Topic; D018795:Device Approval; D006353:Heart-Assist Devices; D006801:Humans; D018401:Sample Size; D014481:United States; D014486:United States Food and Drug Administration