title: How much clinical evidence is enough: regulation of medical devices?
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Viviano
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Baxley