title: High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.
abstract: 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.
authors.affiliation: Department of Cardiology, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.
authors.forename: Christopher S D
authors.initials: CS
authors.lastname: Almond
authors.forename: Eric A
authors.initials: EA
authors.lastname: Chen
authors.forename: Michael R
authors.initials: MR
authors.lastname: Berman
authors.forename: Joanne R
authors.initials: JR
authors.lastname: Less
authors.forename: J Timothy
authors.initials: JT
authors.lastname: Baldwin
authors.forename: Sarah R
authors.initials: SR
authors.lastname: Linde-Feucht
authors.forename: Tracey R
authors.initials: TR
authors.lastname: Hoke
authors.forename: Gail D
authors.initials: GD
authors.lastname: Pearson
authors.forename: Kathy
authors.initials: K
authors.lastname: Jenkins
authors.forename: Brian W
authors.initials: BW
authors.lastname: Duncan
authors.forename: Bram D
authors.initials: BD
authors.lastname: Zuckerman
mesh_terms: 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