title: The FDA's response to the GAO's report: new effort to tighten the pre-market review process for select Class III medical devices.
authors.affiliation: McGuireWoods Chicago, USA.
authors.forename: Ji Hye
authors.initials: JH
authors.lastname: Kim
authors.forename: Jessica
authors.initials: J
authors.lastname: Smith
authors.forename: Jason
authors.initials: J
authors.lastname: Greis
authors.forename: Kristian
authors.initials: K
authors.lastname: Werling
mesh_terms: D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration