Published online June 29, 2009
PEDIATRICS Vol. 124 No. 1 July 2009, pp. e155-e162 (doi:10.1542/peds.2008-3726)
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SPECIAL ARTICLE

Pathways to Approval of Pediatric Cardiac Devices in the United States: Challenges and Solutions

Robert H. Beekman, III, MDa, Brian W. Duncan, MD, MBAb, Donald J. Hagler, MDc, Thomas K. Jones, MDd, John D. Kugler, MDe, John W. Moore, MD, MPHf, Kathy J. Jenkins, MD, MPHg for the Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics

a Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
b Division of Cardiac Surgery, Cleveland Clinic Foundation, Cleveland, Ohio
c Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota
d Division of Pediatric Cardiology, Seattle Children's Hospital, Seattle, Washington
e Division of Pediatric Cardiology, Children's Hospital of Omaha, Omaha, Nebraska
f Division of Pediatric Cardiology, San Diego Children's Hospital, San Diego, California
g Department of Cardiology, Children's Hospital Boston, Boston, Massachusetts

Patients treated by pediatric interventional cardiologists and cardiac surgeons often have unmet medical device needs that pose a challenge to the current regulatory evaluation and approval process in the United States. In this report we review current US Food and Drug Administration regulatory processes, review some unique aspects of pediatric cardiology and cardiac surgery that pose challenges to these processes, and discuss possible alternate pathways to cardiac device evaluation and approval for children. Children deserve to benefit from new and refined cardiac devices and technology designed explicitly for their conditions.

Key Words: cardiac devices • medical devices • device approval • pediatric cardiology

Abbreviations: FDA—Food and Drug Administration • IDE—investigational device exemption • PMA—premarket approval • HDE—humanitarian device exemption • HUD—humanitarian use device • OPC—objective performance criteria • PG—performance goal • OUS—outside the United States

Accepted Feb 27, 2009.


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R. H. Beekman III
Alternatives proposed for pediatric cardiac device approval
AAP News, July 1, 2009; 30(7): 16 - 16.
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