title: Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address: holmes.david@mayo.edu.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: FDA Center for Devices and Radiological Health, Silver Spring, Maryland.
authors.forename: Jeff
authors.initials: J
authors.lastname: Shuren
authors.affiliation: FDA Office of Commissioner, Silver Spring, Maryland.
authors.forename: Robert
authors.initials: R
authors.lastname: Califf
authors.affiliation: FDA Center for Devices and Radiological Health, Silver Spring, Maryland.
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
authors.affiliation: FDA Center for Devices and Radiological Health, Silver Spring, Maryland.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Abel
authors.affiliation: FDA Center for Devices and Radiological Health, Silver Spring, Maryland.
authors.forename: Andrew
authors.initials: A
authors.lastname: Farb
authors.affiliation: Division of Cardiology, Columbia University Medical Center-NY Presbyterian Hospital, New York, New York.
authors.forename: Martin
authors.initials: M
authors.lastname: Leon
authors.affiliation: Department of Cardiovascular Surgery, Baylor Scott & White Health, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D005240:Feasibility Studies; D018166:Health Care Reform / Q000331:legislation & jurisprudence*; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D020416:Outsourced Services / Q000331:legislation & jurisprudence*; D061214:Patient Safety; D016730:Program Development; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*