title: Patient access to medical devices--a comparison of U.S. and European review processes.
authors.affiliation: Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD, USA.
authors.forename: Saptarshi
authors.initials: S
authors.lastname: Basu
authors.forename: John C
authors.initials: JC
authors.lastname: Hassenplug
mesh_terms: D018795:Device Approval; D004864:Equipment and Supplies; D005060:Europe; D006297:Health Services Accessibility; D006801:Humans; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration