Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.
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.
Beekman
Robert H
RH
Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. rbeekman@cchmc.org
Duncan
Brian W
BW
Hagler
Donald J
DJ
Jones
Thomas K
TK
Kugler
John D
JD
Moore
John W
JW
Jenkins
Kathy J
KJ
D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D002309:Cardiology / Q000295:instrumentation*; D002648:Child; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004867:Equipment Design; D006321:Heart / Q000033:anatomy & histology; D006801:Humans; D007231:Infant, Newborn; D010372:Pediatrics / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D012042:Registries; D035703:Therapies, Investigational / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult