title: Food and Drug Administration commentary on "a new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves".
authors.affiliation: Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Md. Electronic address: fernando.aguel@fda.hhs.gov.
authors.forename: Fernando
authors.initials: F
authors.lastname: Aguel
authors.forename: Steven B
authors.initials: SB
authors.lastname: Kurtzman
authors.forename: Sonna
authors.initials: S
authors.lastname: Patel-Raman
authors.forename: Matthew
authors.initials: M
authors.lastname: Hillebrenner
authors.forename: Bram D
authors.initials: BD
authors.lastname: Zuckerman
mesh_terms: D018795:Device Approval; D006330:Heart Defects, Congenital / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006351:Heart Valves / Q000601:surgery*; D006801:Humans; D008389:Marketing of Health Services; D014486:United States Food and Drug Administration
keywords: 20; 35; 35.3; 4.2