Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.

Publisher: American Academy of Pediatrics Country of Publication: United States NLM ID: 0376422 Publication Model: Print Cited Medium: Internet ISSN: 1098-4275 (Electronic) Linking ISSN: 00314005 NLM ISO Abbreviation: Pediatrics Subsets: MEDLINE

Publication: Elk Grove Village Il : American Academy of Pediatrics
Original Publication: Springfield, Ill., Thomas.

Device Approval*/legislation & jurisprudence ; Device Approval*/standards; Cardiac Surgical Procedures/*instrumentation ; Cardiology/*instrumentation ; Pediatrics/*instrumentation; Child ; Equipment Design ; Heart/anatomy & histology ; Humans ; Infant, Newborn ; Product Surveillance, Postmarketing ; Registries ; Therapies, Investigational/instrumentation ; United States ; United States Food and Drug Administration ; Young Adult

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.

Date Created: 20090701 Date Completed: 20090922 Latest Revision: 20090630

20221213

10.1542/peds.2008-3726

19564262