title: The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.
abstract: The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Ashley
authors.initials: A
authors.lastname: Adamovich
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Susie
authors.initials: S
authors.lastname: Park
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.. Electronic address: sisking@mail.amc.edu.
authors.forename: Gary P
authors.initials: GP
authors.lastname: Siskin
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Meridith J
authors.initials: MJ
authors.lastname: Englander
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Mandato
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Allen
authors.initials: A
authors.lastname: Herr
authors.affiliation: Department of Radiology, Albany Medical Center, 47 New Scotland Ave., MC-113, Albany, NY 12208.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Keating
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D015642:Radiology, Interventional / Q000295:instrumentation* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*