title: The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Vinay K
authors.initials: VK
authors.lastname: Rathi
authors.affiliation: Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.affiliation: Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut4Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D000288:Administrative Personnel / Q000331:legislation & jurisprudence; D002309:Cardiology / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006353:Heart-Assist Devices / Q000009:adverse effects / Q000706:statistics & numerical data; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*