title: The US Food and Drug Administration Premarket Approval Process and the 515 Program Initiative: View From a Panel Chair.
authors.affiliation: Division of Cardiovascular Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Page
mesh_terms: D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration