Left to their own devices: breakdowns in United States medical device premarket review.
Hines
Jonas Zajac
JZ
Health Research Group at Public Citizen, Washington, DC, United States of America. jonas.hines@ucsf.edu
Lurie
Peter
P
Yu
Eunice
E
Wolfe
Sidney
S
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