title: Left to their own devices: breakdowns in United States medical device premarket review.
authors.affiliation: Health Research Group at Public Citizen, Washington, DC, United States of America. jonas.hines@ucsf.edu
authors.forename: Jonas Zajac
authors.initials: JZ
authors.lastname: Hines
authors.forename: Peter
authors.initials: P
authors.lastname: Lurie
authors.forename: Eunice
authors.initials: E
authors.lastname: Yu
authors.forename: Sidney
authors.initials: S
authors.lastname: Wolfe
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000266:history / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007883:Legislation, Medical; D014481:United States; D014486:United States Food and Drug Administration